Dietary supplement recalls total 20 in 1997; 12 related to digitalis.

DIETARY SUPPLEMENT RECALLS UP 100% TO 20 IN 1997, up from the 10 reported in 1996 based on an analysis of FDA's weekly "Enforcement Report" of company reported recalls. OTC drug recalls dropped to 35, from 36 in 1996. The OTC drug recalls in 1997 included 13 solid oral dosage products, seven oral liquids, 12 topicals, one ophthalmic, one nasal spray and one suppository product.

In addition to OTCs and dietary supplements, the list of 1997 recalls compiled by "The Tan Sheet" includes foods, infant formulas, home test kits, eyecare, condoms and topical products, totals 67. Product contamination was cited most commonly (29 times) as the reason for the recalls.

The increase in 1997 dietary supplement recalls is primarily a result of 12 recalls of plantain-containing supplements contaminated with potentially lethal digitalis glycosides. The digitalis contamination was eventually traced back to a bulk shipment of digitalis that was mistaken for plantain by German importers ("The Tan Sheet" Nov. 3, 1997, p. 15).

The digitalis incident accounted for all but two of the year's Class I ("violative product poses reasonable probability of serious adverse health consequences or death") recalls in the aforementioned categories. Only one Class I recall was recorded for OTC drugs and dietary supplements in both 1996 and 1995.

Of the remaining two Class I recalls for 1997, Nestle recalled lots of its Carnation infant formula, that "may have been produced under unsanitary conditions" and were "linked with mild gastrointestinal illness." Cheminova America recalled Aerosols Preval Skin Cap spray, cream and shampoo for treatment of baby's cradle cap because of the "presence of undeclared clobetasol propionate (corticosteroids)."

Class III recalls (those "not likely to cause adverse health consequences") accounted for the largest number of OTC and dietary supplement product actions in 1997 with 30. Class II recalls, for products that "may cause temporary or medically reversible adverse health consequences," totaled 23.

Product performance was cited as the reason for Ansell's massive recall of approximately 57 mil. Lifestyles, Prime and Contempo condoms ("The Tan Sheet" Oct. 27, 1997, p. 5). The products were recalled voluntarily by the Eatontown, N.J.-based company due to concerns that deterioration during shelf life may have compromised the condoms' ability to protect against pregnancy and/or sexually transmitted disease. Ansell twice recalled Lifestyles condoms in 1996.

Potency and content uniformity problems were the most common reason for companies issuing product recalls for OTC drugs, which totaled 15; there was only one dietary supplement recall in 1997 for a potency and content uniformity problem.

Labeling and packaging related recalls hit 18 during the year, 10 of which were OTC products. That number is down one third from the 1996 labeling and packaging related OTC drug and dietary supplement total of 15. Other product categories drawing labeling and packaging recalls were dietary supplements (three), home test kits (two), and meal replacements, eyecare and infant formula, with one each.

[EDITORS' NOTE: A complete rundown of 1997 OTC and prescription drug recalls appears in the January issues of F-D-C Reports' "The Gold Sheet." For a trial subscription, contact Ed Picken at [phone].]

OTC DRUG SUPPLEMENT PRODUCT RECALLS IN 1997: Information on product recalls has been collected and categorized by "The Tan Sheet" from FDA's "Enforcement Report" issued weekly during 1997. There is often a delay between the issuance of a recall by a company and its appearance in the "Enforcement Report." Therefore, some recalls begun in 1997 may not appear until 1998.

FDA designates a recall as falling into one of three classes according to the health threat posed by the problem product: Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III D violative product not likely to cause adverse health consequences. Potency/Content Uniformity Product............ Alcoholado Alcanformentol 70, OTC Mfr./Recaller...... Specialties Chemical Class.............. III Reason............. Incorrect product formulation - isopropyl alcohol used instead of ethyl alcohol. Potency/Content Uniformity Product............ Benadryl Itch Stopping gel, original strength (1%) Mfr./Recaller...... Paco Pharmaceutical Services/Warner-Lambert Class.............. III Reason............. Product fails to meet zinc acetate content specifications throughout shelf-life (stability). Potency/Content Uniformity Product............ Betuline lotion Mfr./Recaller...... Ferndale Labs Class.............. III Reason............. Superpotency - methyl salicylate (stability). Potency/Content Uniformity Product............ Gojo hand medic antiseptic skin treatment, OTC Mfr./Recaller...... Gojo Industries Class.............. III Reason............. Subpotent - recalled lots do not contain the sole active ingredient, benzalkonium chloride. Potency/Content Uniformity Product............ Hemorrhoidal suppositories Mfr./Recaller...... G&W Labs Class.............. III Reason............. Subpotent; Phenylephrine. Potency/Content Uniformity Product............ Histalet Forte tablets Mfr./Recaller...... Milkart Class.............. III Reason............. Product failed content uniformity (validation). Potency/Content Uniformity Product............ Ibuprofen tablets Mfr./Recaller...... Knoll Pharmaceutical Class.............. III Reason............. Dissolution specification failure. Potency/Content Uniformity Product............ Infants' Tylenol acetaminophen drops USP Mfr./Recaller...... McNeil La Compagnie de Produits, Aux Consummateurs McNeil/Edreiss Trading Class.............. II Reason............. The product contains unapproved sweetener, sodium cyclamate. Potency/Content Uniformity Product............ Maximum Strength Ecotrin caplets Mfr./Recaller...... SmithKline Beecham Pharmaceutical Class.............. II Reason............. Product failed dissolution testing (stability). Potency/Content Uniformity Product............ Orudis KT caplets Mfr./Recaller...... Whitehall-Robins Labs Class.............. III Reason............. Content uniformity failure. Potency/Content Uniformity Product............ OTC Skin Cap spray, cream and shampoo Mfr./Recaller...... Aerosols Preval/Cheminova America Class.............. I Reason............. Presence of undeclared clobetasol propionate (corticosteroids). Potency/Content Uniformity Product............ Regular strength enteric-coated aspirin tablets Mfr./Recaller...... Granutec Class.............. II Reason............. Failing dissolution results in stability testing. Potency/Content Uniformity Product............ Revco brand decongestant cold tablets; multi-symptom Mfr./Recaller...... Pharmaceutical Formulations Class.............. III Reason............. Product failed content uniformity for chlorpheniramine maleate due to low tablet weights. Potency/Content Uniformity Product............ Senna Gen tablets Mfr./Recaller...... Concord Labs/Heartland HealthCare Services Class.............. III Reason............. Incorrectly declared potency - Product labeled as containing 187 mg Senna concentrate (5.6 mg Sennosides), but actually contains 8.6 mg Sennosides. Potency/Content Uniformity Product............ "The" Daily Multiple tablets Mfr./Recaller...... Bactolac Pharmaceuticals Class.............. II Reason............. Product is subpotent in folic acid. Potency/Content Uniformity Product............ Tussex-DM expectorant cough suppressant Mfr./Recaller...... Ferndale Labs Class.............. III Reason............. Ingredient non-uniformity. Contamination Product............ Bio-Safe antibacterial lotion Mfr./Recaller...... Stanford Personal Care/ Bio-Safe Skin Products Class.............. II Reason............. Product is contaminated with Pseudomonas aeruginosa. Contamination Product............ Blessed Herbs plantain herb, wildcrafted Mfr./Recaller...... Blessed Herbs Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Carnation follow-up infant formula Mfr./Recaller...... Nestle Food Company/ Nestle USA Class.............. I Reason............. The product is adulterated because it may have been produced under unsanitary conditions whereby it may have been rendered injurious to health. Furthermore, the product appears separated and has been linked with mild gastrointestinal illness. Contamination Product............ Children's chewable vitamins Mfr./Recaller...... ADH Health Product Class.............. II Reason............. The products contain excessive levels of lead. Contamination Product............ Children's chewable vitamins w/iron Mfr./Recaller...... Archon Vitamin Class.............. II Reason............. Product contains excessive levels of lead. Contamination Product............ Cleansing Herbal Dietary Supplement Mfr./Recaller...... ABCO/Arise & Shine Class.............. I Reason............. The product was contaminated with digitalis. Contamination Product............ Dietary supplements Mfr./Recaller...... Manhattan Drug Company Class.............. II Reason............. Products contain excessive levels of lead. Contamination Product............ Extra Strength Tylenol (acetaminophen) gelcaps Mfr./Recaller...... McNeil Consumer Products Company Class.............. III Reason............. Microbial contamination of non-sterile product (gelatin coating exceeded internal specification for aerobic microorganisms). Contamination Product............ Gentle Lotion cleanser; Triple S Gentle wash Mfr./Recaller...... Sani-Fresh International Class.............. II Reason............. The product is contaminated with Psuedomonas aeruginosa. Contamination Product............ Health Safe antibacterial/antiseptic polymer lotion Mfr./Recaller...... Stanford Personal Care Manufacturer/AmeriCare Health Products Class.............. II Reason............. Product contamination with Pseudomonas aeruginosa. Contamination Product............ Mead Johnson Magnacal Renal Mfr./Recaller...... Mid-American Dairymen/Mead Johnson Nutritionals Class.............. II Reason............. The product was found contaminated with Bacillus and Cellumonas bacteria. It is also unfit for food based on thickening and gelling. Contamination Product............ Nature Cleanse tablets Mfr./Recaller...... National Nutritional Labs/Natural Organics Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Oxy 10 medicated face wash Mfr./Recaller...... SmithKline Beecham Consumer Healthcare Class.............. II Reason............. Product contaminated with Burkholderia cepacia. Contamination Product............ Petite Regime sunscreen Mfr./Recaller...... Arizona Natural Resources/Gymboree Corporation Class.............. III Reason............. Product contamination with Psuedomonas putida. Contamination Product............ Plantain and herbal extracts Mfr./Recaller...... Ameriherb/Pure Herb Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Plantain extract Mfr./Recaller...... Good Herbs Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Plantain leaf; Abbo-Mends tea Mfr./Recaller...... Jean's Greens Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Plantain Leaves Mfr./Recaller...... Ameriherb Class.............. I Reason............. Product was contaminated with digitalis glycosides. Contamination Product............ Plantain Leaves Mfr./Recaller...... Herbarium Class.............. I Reason............. Product was contaminated with digitalis glycosides. Contamination Product............ Plantain Leaves Mfr./Recaller...... Nature's Cathedral Class.............. I Reason............. Product was contaminated with digitalis glycosides. Contamination Product............ Plantain Leaves Mfr./Recaller...... Pacific Botanicals Class.............. I Reason............. The product was contaminated with digitalis glycosides. Contamination Product............ Plantain Leaves Mfr./Recaller...... Trinity Herb Class.............. I Reason............. Product was contaminated with digitalis glycosides. Contamination Product............ Target brand creamy baby oil Mfr./Recaller...... Benjamin Ansehl Class.............. II Reason............. Product is contaminated with Burkholderia cepacia, a pathogen. Contamination Product............ Triaminic Night Time maximum strength Mfr./Recaller...... Novartis Consumer Health Class.............. II Reason............. Possible compressor oil contamination. Contamination Product............ Uriseptic tea Mfr./Recaller...... Wise Woman Herbals Class.............. I Reason............. Product was contaminated with digitalis glycosides. Contamination Product............ Veragel 1:1 purified aloe vera leaf water soluble extract Mfr./Recaller...... Madis Botanicals Class.............. II Reason............. The product is contaminated with Enterobacter gergoviae, an opportunistic pathogen. Contamination Product............ Vita Squares Mfr./Recaller...... Natural Formulas Class.............. II Reason............. Product contained excessive levels of lead. Contamination Product............ Vitamin mineral premixes Mfr./Recaller...... Fortitech Class.............. II Reason............. The ferrous fumarate used in the manufacture of these premixes contained excessive levels of lead. Labeling/Packaging Product............ Acetaminophen tablets Mfr./Recaller...... AAA Pharmaceutical Class.............. III Reason............. Labeling - incorrect lot number. Labeling/Packaging Product............ Amway Formucare hydrocortisone cream USP Mfr./Recaller...... Thames Pharmacal/ Amway Class.............. II Reason............. Packaging mix-up: Some correctly labeled tubes of hydrocortisone cream were packaged into exterior cartons labeled as triple antibiotic ointment. Labeling/Packaging Product............ Apothecary Products OTC drug pouches Mfr./Recaller...... Apothecary Products Class.............. II Reason............. Mispackaged. The convenience packs are held on a 15-prong display as a labeled card holding a labeled pouch of one adult drug dosage. The cards are incorrectly labeled; however, the pouches each holding the products are correctly labeled with the actual product each contains. The convenience packs labeled as containing Maximum Strength Tylenol Sinus actually contain Sudafed 30 mg Psuedoephedrine Hydrochloride Tablets (2). The pouch holding the product is correctly labeled as Sudafed. The convenience packs labeled as containing Maximum Strength Aspirin Free Anacin actually contain Bayer Aspirin Tablets (2), 325 mg per tablet. The pouch holding the product is correctly labeled as Bayer Aspirin. Labeling/Packaging Product............ Aspirin-Free Excedrin extra strength caplets Mfr./Recaller...... Bristol-Myers Products Class.............. III Reason............. Labeling - Carton incorrectly lists aspirin as ingredient. Labeling/Packaging Product............ Aspirin tablets Mfr./Recaller...... LNK International/Heartland HealthCare Services Class.............. II Reason............. Mislabeling - Uncoated tablets labeled as "enteric coated." Labeling/Packaging Product............ Bausch & Lomb Muro 128 5% ophthalmic Mfr./Recaller...... Bausch & Lomb Pharmaceuticals Class.............. III Reason............. Labeling mix-up - some tubes may be mislabeled as containing erythromycin ointment; the actual tube contents are Muro 128 and the unit carton label is correct. Labeling/Packaging Product............ Confide HIV Home Test Kit - Federal Express Mailers Mfr./Recaller...... Direct Access Diagnostics Class.............. III Reason............. Federal Express mailer packages were incorrectly attached to a competitor firm's packaged product and distributed. Labeling/Packaging Product............ Dietary Supplements Mfr./Recaller...... EFS-Herbal Drops Class.............. III Reason............. The labels are illegible. Labeling/Packaging Product............ Ensure Plus Mfr./Recaller...... Ross Products Division Class.............. III Reason............. Product bears the label of another food and contains erroneous label information regarding identity and nutrient content. Labeling/Packaging Product............ Infants' Simethicone drops Mfr./Recaller...... Vintage Pharmaceuticals Class.............. III Reason............. Product released without tamper-evident neck band. Labeling/Packaging Product............ Isomil brand soy protein infant formula with iron Mfr./Recaller...... Abbott Labs/First National Supermarkets Class.............. III Reason............. The infant formula does not contain the labeled amount inositol, a nutrient required under 21 CFR section 107.100. This product was originally formulated for distribution in the United Kingdom, which does not require the addition of inositol. Labeling/Packaging Product............ Mechanical Servants brand Regular Afrin nasal decongestant 12 hour nasal spray Mfr./Recaller...... Schering-Plough Healthcare Products/Mechanical Servants Class.............. III Reason............. Some outer packages are labeled with an incorrect expiration date (the expiration date may appear as "10/97" or "6/98"). The bottles bear the correct expiration date. Labeling/Packaging Product............ Metamucil powder Mfr./Recaller...... Proctor & Gamble Class.............. III Reason............. Misbranding - product labeled to contain aspartame but actually contains sucrose sugar. Labeling/Packaging Product............ Nations Winners brand Spark of Life multi-nutritional drink Mfr./Recaller...... Aloe Pro International Class.............. II Reason............. Product contains undeclared FD&C Yellow No. 5 and bears an incorrect vitamin C label declaration. Labeling/Packaging Product............ One Touch test strips Mfr./Recaller...... Lifescan Class.............. II Reason............. The lot of glucose test strips was labeled with an incorrect calibration code which causes glucose results to be inaccurately high. Labeling/Packaging Product............ OTC vitamin/amino acid/mineral products Mfr./Recaller...... Natureade/Performance Nutrition Class.............. III Reason............. Product insert makes unapproved drug claims related to attention deficit hyperactivity disorder. Labeling/Packaging Product............ Phenadex pediatric cough & cold drops Mfr./Recaller...... Alpharma Class.............. III Reason............. Failure to apply tamper evident seals. Labeling/Packaging Product............ TLC hospital lotion Mfr./Recaller...... Polychem Class.............. III Reason............. Some bottles may be labeled as TLC Mouth Rinse. Other Spec Problems Product............ Benadryl Itch Stopping gel 2% extra strength Mfr./Recaller...... Paco Pharmaceutical Services/ Warner-Lambert Consumer Healthcare Division Class.............. III Reason............. Product fails to meet zinc acetate content specifications through shelf-life (stability). Other Spec Problems Product............ Bio-Safe antibacterial lotion (triclosan .3%) Mfr./Recaller...... Stanford Personal Care Manufacturing/Bio-Safe Skin Products Class.............. III Reason............. Separation of lotion. Other Spec Problems Product............ Guiatuss AC Mfr./Recaller...... Alpharma Class.............. III Reason............. Presence of precipitate. Other Spec Problems Product............ Panmist S guaifenesin orange-flavored syrup Mfr./Recaller...... Sage Pharmaceuticals Class.............. III Reason............. Guaifenesin may precipitate. Product Performance Product............ Condoms with nonoxynol Mfr./Recaller...... Ansell Class.............. II Reason............. The devices may have defects which could cause breakage during use.