OTC, Nutritional Recalls Increase Almost 30% Collectively In 2001

Firm-initiated recalls of OTCs and dietary supplements rose 29.9% collectively in 2001 compared to 2000, based on a compilation of FDA's weekly reports of recalls and court actions.

Among the primary contributors to the increase were supplements recalled due to the presence of aristolochic acid. FDA issued an import alert on the herbal in July 2000 in response to reports linking the substance to kidney failure (¹ (Also see "Aristolochic acids" - Pink Sheet, 17 Jul, 2000.), p. 28).

Twenty products manufactured by nine companies, including the Chinese firms Lotus Herb, Sheng Chang Pharmaceutical and Tainjiang Pharmaceutical, were recalled for containing the banned ingredient, which also has been tied to cases of urothelial cancer.

Each of the nine recalls were classified as Class I, or "poses reasonable probability of serious adverse health consequences or death."

Overall, FDA reported 87 OTC and nutritional recalls in 2001, compared to 67 in 2000 and 63 in 1999.

Six nutritional product withdrawals stemmed from Salmonella detected in batches of bulk pepsin manufactured by Omaha, Neb.-based American Labs.

In an April 27 "Talk Paper," FDA noted Solgar was recalling 754 bottles of its Digestive Aid 100's after being notified by supplier American Labs of the contamination problem (² (Also see "Solgar Digestive Aid 100's Recall One-Third Complete, AHP Division Says" - Pink Sheet, 7 May, 2001.), p. 16).

A subsequent recall involved the removal of Biotics Research's Hydrozyme Tablets and HCl Plus Tablets due to Salmonella contamination found in American Labs' pepsin.

In November, one week after the Eclectic Institute had 76 bottles of its Opti Gest 1 supplement pulled for the same reason, American Labs withdrew all outstanding drums of bulk pepsin and bulk pepsin powder.

For OTCs, internal analgesics continued to be the most frequently recalled category, with 10 products withdrawn, compared to nine in 2000. One internal analgesic was recalled for labeling reasons, while the other nine had potency/content uniformity problems.

LNK International was involved in three of the recalls, pulling bottles of its Aspirin Tablets, Enteric Coated Aspirin Tablets and Extra Strength Enteric-Coated Aspirin Tablets due to dissolution test failures.

Perrigo initiated a Class I recall in June of three private label brands of its Children's Pain Reliever due to acetaminophen superpotency; the products were supposed to contain 80 mg acetaminophen per dose.

Problems with pouch seals of three scented adhesive patch products culminated in a firm-initiated recall by Minnetonka, Minn.-based LecTec of TheraPatch Vapor Nose & Chin Cough Suppressant, TheraPatch Vapor Chest Cough Suppressant and Triaminic Vapor Patch with Menthol Scent on Feb. 7.

Novartis Consumer Healthcare, which markets the Triaminic patch under a multi-year supply agreement with LecTec, was forced to withdraw more than 220,000 menthol-scented vapor patches at the end of 2000 and start of 2001 as a result of the Class III recall (³ (Also see "Novartis/LecTec Triaminic Vapor Patch Recall Replacements Shipping" - Pink Sheet, 18 Dec, 2000.), p. 5).

LecTec appears to have corrected the pouch manu-facturing problem; the company plans to begin shipping its first Therapatch aromatherapy pouch in February (⁴ (Also see "TheraPatch Sinus & Allergy Marks LecTec Debut In Aromatherapy" - Pink Sheet, 14 Jan, 2002.), p. 5).

Overall, 23 of the recalls were designated Class I, 21 were classified Class II, or "may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote," and 43 were deemed Class III, or "violative product not likely to cause adverse health consequences."

Of the 2001 recalls, 63 were for OTC drug products, a 53.6% jump over previously steady levels in 2000 and 1999. However, the 22 dietary supplement recalls in 2001 did not represent as significant an increase compared to the 20 and 15 supplement recalls during the past two years, respectively. The two remaining recalls were for OTC medical devices.

[Editors' note: A complete rundown of 2001 OTC, Rx, and biologics recalls will appear in the March issue of F-D-C Reports' "The Gold Sheet." For a trial subscription, contact customer service at 1 [phone].]