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FDA Recalls For Nov 30 and Dec. 7, 2011

This article was originally published in The Tan Sheet

FOODS - CLASS II

1) Peptide Bonded Glutamine, 500 g and 1000 g; 2) CNP Professional ProPeptide MBF, Vanilla, 1 lb, 5 lbs (2270 g), and 10 lb; 3) CNP Professional ProMR Chocolate, 5 lb and 72 g; 4) CNP Professional ProMR Creamy Vanilla, 5 lb and 72 g packages; 5) CNP Professional ProPeptide, Creamy Vanilla, 2 lb bottle and 5 lb bag; 6) Kodiak Strength ProPeptide Vanilla Flavor 2 lbs (908 g); 7) Muscle Meals High-Protein Meal Replacement, Dutch Chocolate Smoothie, 2.6 oz (73 g); 8) Muscle Link RecoverX, Creamy Orange 3 lbs 14 oz (1760 g); 9) Muscle Link ProFusion, Creamy Orange 2 lbs (907 g); 10) Healthy Planet Nutrition The Purest Whey Protein, Creamy Vanilla, 21 oz; 11) Bill Pearl's Champion's Choice High Protein Oatmeal 7 lb and 20.5 oz packages; 12) Muscle Meals High Protein Meal Replacement, Creamy Smooth Vanilla, 2.6 oz (73 grams); 13) CNP Professional Pro Dessert Instant Protein Pudding Mix, Vanilla, 39 grams; 14) Muscle Link Pro Fusion, New Chocolate Fudge, 2 lbs. (907 gm); 15) CNP Professional PROGF Pre-Workout Supplement, Lemonade, 1260 grams (2.78 pounds); 16) Muscle Link Pro Fusion, New Tropical Vanilla, 2 lbs. (907 gm); 17) CNP Professional High Performance GF Pre Workout Supplement, Fruit Punch, 1260 gram (2.78 pounds) and 42 gram; 18) CNP Professional ProGF Pre Workout Supplement, Fruit Punch, 2.78 pounds (1260 grams ); 19) CNP Professional High Performance GF Pre Workout Supplement, Grape, 42 grams; 20) CNP Professional Pro-Ms Body Sculpting Protein for Women, Vanilla Caramel, 47 gram package; 21) CNP Professional Pro-Ms Body Sculpting Protein for Women, Swiss Chocolate, 1 lb and 47 gram packages; 22) CNP Professional Pro-Ms Body Sculpting Protein for Women, Wild Berries and Cream, 47 gram packages; 23) Body Tech Pro-Pudding Dutch Chocolate, 1.44 oz. (41 g); 24) Body Tech Pro-Pudding Vanilla Creme, 1.38 oz. (39 g); 25) SMS Size, Mass, Strength, Chocolate, 10 lbs. (4540.2 g); 26) SMS Size, Mass Strength, Vanilla, 10 lbs. (4540.2 g); 27) SUN Samimi Unique Nutrition, Super Mass Gainer, Vanilla, 5 lb and 12 lb packages; 28) SUN Samimi Unique Nutrition, Super Mass Gainer, Chocolate, 5 lb and 12 lb packages; 29) SUN Samimi Unique Nutrition, Super Mass Gainer, Strawberry, 5 lb and 12 lb packages; 30) Sunplex, SUN Samimi Unique Nutrition, Advanced Protein Meal Replacement, Strawberry, 14-72 g pouches per box (1008 g); 31) Sunplex, SUN Samimi Unique Nutrition, Advanced Protein Meal Replacement, Chocolate Malt, 14-72 g pouches per box (1008 g); 32) CNP Professional ProPeptide, Strawberry, 1 lb, 2 lb bottle and 5 lb bag; 33) CNP Professional ProPeptide, Chocolate, 1 lb, 2 lb bottle and 5 lb bag; 34) CNP Professional ProPeptide, Banana, 1 lb, 2 lb bottle and 5 lb bag; 35) CNP Professional Pro Dessert Instant Protein Pudding Mix, Chocolate, 39 grams; 36) CNP Professional ProPeptide MBF, Strawberry, 1 lb and 10 lb; 37) CNP Professional ProPeptide MBF, Chocolate, 1 lb and 10 lb; 38)CBG 1000; 39) CNP Professional ProGF Pre Workout Supplement, Lemonade, 2.78 pounds (1260 grams ); 40) Progenex Recovery Vanilla, 1 lb and 2.38 lb; 41) Progenex Recovery Chocolate, 1 lb and 2.45 lb; 42) Natura HP Beyond Whey 300 g bottle; 43) Weider Nutrition Dynamic Muscle Builder Adv, Vanilla, 2 lb; 44) Weider Nutrition Dynamic Muscle Builder Adv, Chocolate, 2 lb; 45) Weider Nutrition Dynamic Muscle Builder Adv, Chocolate, 2 lb

No lot numbers indicated.

Manufacturer:

Expro Manufacturing Corp., Vernon, CA

Recalled by:

Manufacturer, by visit beginning Sept. 22, 2011. FDA -initiated recall is ongoing.

Distribution:

349,106 units; AZ, CA, OR, NJ and NM

Reason:

Products contain the allergen wheat and does not declare wheat on the product label.

Recall

number:

F-0171/0215-2012

DRUGS - CLASS I

Uprizing 2.0 capsules (13-ethyl-3-methoxy-gona-2,5(10),-dien-17-one 30 mg; 4-Chloro-17a-Methyl-Androsta-1,4-diene-3,17-diol 17.5 mg; 2a 17a dimethyl etiocholan 3, one 17b-ol 10 mg), 90-count capsules per bottle; UPC: 2657061476

All lots

Manufacturer:

Chaotic Labz, Dover, AR

Recalled by:

Superior Metabolic Technologies, Kennesaw, GA, by telephone and letter on Aug. 5, 2011, and by press release on Oct.3, 2011. FDA-initiated recall is complete.

Distribution:

243 bottles; nationwide

Reason:

Marketed without an approved NDA/ANDA: FDA analysis found the product to contain a synthetic steroid, making Uprizing 2.0 capsules an unapproved new drug.

Recall number:

D-864-2012

Celerite Slimming Tea, 25 tea bags (2 g each) in box; Made in China.

All lots sold by this firm in the past 12 months.

Manufacturer:

H&S GMP Factory, Kunming, China

Recalled by:

Shaping Beauty, Inc., Huntingdon Valley, PA, via email on March 17, 2011, and press release on March 24, 2011. FDA-initiated recall is ongoing.

Distribution:

257 boxes of 25 tea bags each; nationwide

Reason:

Marketed without an approved NDA/ANDA: Product was found to contain undeclared sibutramine.

Recall number:

D-713-2012

1) Bausch & Lomb Soothe XP Emollient (Lubricant), Eye Drops, Sterile 0.5 fl oz (15mL), NDC 24208490; 2) Bausch & Lomb Soothe XP Emollient (Lubricant), Eye Drops, Sterile 0.08 fl oz (2.5mL), (PROFESSIONAL SAMPLE-NOT FOR SALE)

1) Lots: 130241 130541 130831 130841 131381 131391 132081 397291 397381 397561 397711 397731 397921 397931 407051 407611 407631 417061 427131 437271 437501 437521 447181 447191 448061 448071 457001 457171 457191 457881 458001 467201 477101 477111 477911 487311 487571 497111 497561 507741 507861 517131 517911 518021 537001 537131 537141 537391 537661 537671 537921 538051 547011 547201 547221 547231 547631 547651 548171 557021 557032 557451;

Manufacturer:

Bausch & Lomb Inc., Tampa, FL

Recalled by:

Manufacturer, by press release and letters on Feb. 24, 2011. Firm-initiated recall is ongoing.

Distribution:

2,772,336 (2.5 mL) & 1,731,225 (15 mL) bottles; nationwide, Puerto Rico, Bermuda, Kuwait, Trinidad, Tobago

Reason:

Lack of assurance of sterility: Bausch & Lomb initiated a recall of Soothe Xtra Protection eye drops due to testing which showed specific lots of the product were trending out of specification for preservative efficacy prior to their listed date of shelf-life. Soothe Xtra Protection may not provide sufficient protection against inadvertent microbial contamination during storage and usage of the product.

Recall number:

D-855/856-2012

DRUGS - CLASS II

1) Lactobacillin Acidophilus, capsule, NDC 00536-7180-01, 07985-4109-10, 43292-5002-02, 54629-0111-01; 2)Lactobacillus, tablet, NDC 08290-2368-50, 63736-0105-06, 64980-0129-50; 3)Lactobacillus capsule, NDC 43292-5002-02; 4)Menthol cough suppressant, lozenge, NDC 63736-0859-46; 5) Multivit/min/lutein – Preservision, NDC 24208-0632-10; 6) Multivitain/multimineral – High Potency, tablet, NDC 00904-5042-60, 54629-0082-01; 7) multivitamin w/ luteinCentrum Silver, tablet, NDC 00904-5486-52, 00904-5486-89; 8) multivitamin/mineral – Aquadeks, tablet, NDC 58914-0014-60. D-655-2012; 9) Multivitamin/mineral – Ccentrum, tablet, NDC 00005-4755-70. Recall # d-656-2012; 10) Multivitamin/multimineral– Centrum, liquid, NDC 00536-2790-59. Recall # d-657-2012; 11) Multivitamin/multimineral – High Potency, liquid, NDC 54838-0010-70. Recall # d-658-2012; 12) Multivitamin-ocular – I-Vite, tablet, NDC 00536-5090-08. Recall # d-659-2012; 13) multivitamins, liquid, NDC 00536-8450-80, 54838-0008-70. Recall # d-660-2012; 14) Multivitamins, tablet, NDC 00536-4046-10, 00536-4660-38. Recall # d-661-2012; 15) Multivitamins w/zinc – Aquadeks, tablet, NDC 58914-0010-06. Recall # d-662-2012; 16) Multivitamins w/zinc – Dailyvite, tablet, NDC 10542-0012-10. Recall # d-663-2012; 17) Multivitamins/minerals w/iron, tablet, NDC 00904-5339-60. Recall # d-664-2012; 18) Multivitamins/minerals/iron/beta-carotene– Dailyvite, tablet, NDC 00536-3546-01, 00536-3546-10. Recall # d-665-2012; 19) Multivitamins/multimineral, tablet, NDC 00005-4758-70, 00536-3442-38, 00536-3445-08, 00536-4661-38, 57896-0531-01. Recall # d-666-2012; 20) Multivitamin – Thera-Plus, NDC 05038-3683-04, 50383-0683-04. Recall # d-667-2012

1) Lot: 0471 0101, Exp 05/19/12; 01A32, Exp 11/17/11; 0HA67, Exp 11/17/11; 341287, Exp 04/19/12; 341335, Exp 04/19/12; 0AB27, Exp 08/11/11; 0JB47, Exp 01/14/12; 9LB16, Exp 06/25/11; OKB04, Exp 03/21/12; 2) Lot: 169273, Exp 08/27/11; 0298769, Exp 12/02/11; 298769, Exp 02/03/12; 0321604, Exp 12/17/11, 12/28/11; 0333181, Exp 02/24/12; 0337514, Exp 04/11/12; O235928, Exp 11/17/11; 42329, Exp 11/30/11; 40999, Exp 10/27/11; 7168-65, Exp 06/03/11; 7168-67, Exp 12/07/11, 01/31/12, 03/31/12; 7168-70, Exp 08/25/11; 7168-71, Exp 12/07/11; 7168-72, Exp 08/25/11, 12/07/11, 12/21/11, 12/29/11; 7168-74, Exp 01/31/12, 02/14/12, 03/09/12; 7168-76, Exp 12/29/11, 01/25/12, 01/26/12, 01/31/12; 7168-77, Exp 03/24/12; 7168-78, Exp 03/06/12, 03/09/12, 03/30/12, 05/08/12; 7168-79, Exp 04/13/12, 04/17/12, 04/19/12, 04/25/12, 05/08/12, 05/10/12, 05/18/12, 05/19/12; 7168-80, Exp 03/24/12, 03/30/12, 04/13/12, 04/19/12, 04/25/12, 05/08/12, 05/10/12, 05/18/12, 05/19/12; 3) Lot: 341287, Exp 02/08/12; 341335, Exp 03/01/12  4) Lot: 10E13, Exp 04/03/12; 5) Lot: 3054FJ712, Exp 06/30/11; 3624GK712, Exp 01/31/12; 4279HK712B, Exp 02/25/12; 4279HK713B, Exp 02/11/12; 4818IK712, Exp 03/06/12, 03/16/12; 5065JJ712, Exp 07/23/11; 5765KJ712, Exp 09/15/11; 5770KJ412, Exp 09/30/11; 5770KJ712, Exp 09/07/11, 10/11/11; 6516LK712, Exp 04/04/12, 04/13/12, 04/25/12; 6898LK712A, Exp 05/05/12; 6) Lot: 102120, Exp 09/20/11, 11/11/11, 11/19/11, 12/22/11, 01/25/12, 03/09/12; 104066, Exp 03/09/12, 04/25/12, 05/19/12; 24558802, Exp 06/15/11, 07/06/11, 07/30/11; 9JB67, Exp 06/02/11; 7) Lot: 33078, Exp 11/16/11; 29311903, Exp 05/11/12; 33078, Exp 02/03/12; 33079, Exp 02/03/12; 8) Lot: 121191B, Exp 04/30/12; 9) Lot: F06200, Exp 03/31/12; 10) Lot: 606547, Exp 01/07/12; 11) Lot: 6230A, Exp 05/04/12; 12) Lot: 05310150, Exp 12/02/11; 0361 0190, Exp 01/11/12, 02/17/12; 1141-0140, Exp 08/19/11; 13) Lot: 608041, Exp 05/03/12; 5972A, Exp 04/06/12; 6099B, Exp 03/16/12; 6133B, Exp 01/19/12; 6193A, Exp 02/18/12, 03/06/12, 03/14/12, 04/07/12; 14) Lot: 103184, Exp 02/29/12; 104021, Exp 03/21/12, 04/19/12; 103206, Exp 05/18/12; 15) Lot: X100373A, Exp 03/01/12; 16) Lot: J08022, Exp 12/15/11, 02/08/12; 17) Lot: 30697, Exp 08/05/11, 08/18/11; 31843, Exp 06/30/11; 31844, Exp 06/10/11; 33031, Exp 08/18/11; 33032, Exp 09/17/11, 10/11/11, 10/22/11, 11/11/11, 11/24/11; 33435, Exp 02/04/12, 03/03/12; 33653, Exp 03/17/12; 18) Lot: 1151 0140, Exp 08/25/11; 0461 0130, Exp 02/14/12; 19) Lot: E07065, Exp 10/31/11; E47329, Exp 08/06/11; E55023, Exp 10/26/11, 11/19/11; E78931, Exp 02/29/12; 102664, Exp 02/04/12; 103430, Exp 03/20/12, 05/16/12; 103181, Exp 02/29/12; 94312, Exp 08/06/11; 101532, Exp 02/14/12; '94312, Exp 10/25/11; 531A01, Exp 05/18/12; 20) Lot: 605422, Exp 11/17/11, 12/01/11, 12/03/11, 12/14/11, 12/20/11, 12/21/11; 606301, Exp 11/30/11, 12/08/11, 12/09/11, 12/15/11, 12/17/11, 01/13/12; 607156, Exp 11/17/11; 600979, Exp 05/31/11; 604100, Exp 06/22/11, 06/25/11, 07/13/11, 07/16/11, 07/30/11, 02/24/12; 604976, Exp 07/02/11, 01/17/12; 605422, Exp 08/12/11, 08/24/11, 08/25/11, 08/27/11, 09/15/11, 09/28/11, 10/29/11, 01/04/12, 01/13/12, 02/11/12, 02/14/12, 02/24/12, 03/01/12, 03/03/12, 03/14/12; 605425, Exp 10/15/11, 10/29/11, 11/04/11, 01/17/12; 606301, Exp 10/29/11; 607156, Exp 12/28/11, 01/13/12, 01/26/12; 607948, Exp 02/11/12, 02/28/12, 03/01/12, 03/10/12, 03/22/12, 03/24/12, 03/29/12, 03/31/12, 04/06/12, 04/12/12, 04/14/12, 05/12/12; 608774, Exp 04/13/12, 04/17/12, 05/01/12, 05/11/12, 05/19/12; 604539A, Exp 02/29/12

Manufacturer:

Aidapak Services LLC, Vancouver, WA

Recalled by:

Manufacturer, by letters on May 27, 2011, May 28, 2011, and May 31, 2011, and by press release on June 1, 2011. FDA-initiated recall is ongoing.

Distribution:

444,936 tablets, capsules, cups, syringes, lozenges, dose packs (including Rx drugs and other products not listed here); AK, CA, OR, NV, WA

Reason:

Penicillin cross contamination: there is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.

Recall number:

D-502-2012; D-503-2012; D-672-2012; D-593-2012; D-652-2012; D-653-2012; D-654-2012; D-655-2012; D-656-2012; D-657-2012;  D-658-2012;  D-659-2012; D-660-2012; D-661-2012; D-662-2012; D-663-2012; D-664-2012; D-665-2012; D-666-2012

1) Children's Panadol Liquid (Acetaminophen), 80 mg, fl. oz., 2 fl. oz. and 4 fl. oz bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1; 2) Children's Panadol Chewable Tablets, (Acetaminophen), 80 mg, 32 ct tablets, UPC: 3-09711-03140-3; 3) Infant's PanadolDrops (Acetaminophen), 80 mg per 0.8 mL dropper, fl. oz. bottles, UPC: 3-12843-21496-5; 4) Panadol Cold & Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 16 Caplets and 2 pouch x 50 packets/carton, UPC 3-09711-05005-3; 5) Maximum Strength Contac Cold + Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 30 packets, 2 caplets per packet. UPC: 3-09711-232405-7; 6) Mejoralito, Children's Liquid (Acetaminophen), 2 fl oz bottles, Code: UPC: 0-53100-44310-9; 7) Mejoralito, Children's Chewable Tablets (Acetaminophen), 80mg, 32 count bottles, UPC: 0-53100-44210-2.; 8) Women's Extra Strength Panadol, Menstrual Relief, Multi-Symptom Caplets, (Acetaminophen 500mg, Pamabrom 25mg), 24 count bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1, UPC 3-09711-21491-2

1) Lot number 0910000169, Exp. Date: Oct 2011; Lot: 0910000062, 0410000063, Exp. Date: Oct 2011, Lot: 0911000059, 0911000250, Exp. Date: Nov 2011, Lot: 1101000183, 1101000229, Exp. Date: Jan 2013, Lot:1103000366, Exp. Date; Feb 13, Lot: 1105000103, Exp. Date: May 2013; Lot 0910000056, 0410000057, 0410000058, 090000059, 0910000245, 0410000246, 0910000247, 0910000248, Exp. Date: Oct 2011, Lot: 1101000184, 1101000185, 1101000230, Exp. Date: Jan 2013, Lot: 1103000367, 1103000368, Exp. Date: Mar 2013; 2) Lot: PA015HE2, Exp. Date: May 2013; Lot: PA047FP1, Exp. Date: Dec 2012; Lot: PA047FP2, Exp. Date: Dec 2012; 3) Lot: 0911000230, 0911000232, Exp. Date: Nov 2011 and 1105000118, May 2013; 4) Lot: PA009HD2, Exp. Date: Oct 2012; Lot PA027HE2, Exp. Date: Nov 2012, Lot: PA065FP, Exp. Date Jun 2012; UPC: 3-09711-05015-2, Lot: PA006AHC1, Exp. Date: Sept 2012, Lot PA007HA1, Exp. Date: Jul 2012, Lot: PA008HD1, Oct 2012, Lot: PA009HB1, Exp. Date: 2012, Lot PA009HE1, Exp. Date: Nov 2012, Lot: PA010HB1, Exp. Date: Aug 2012, Lot: PA016FD1, Exp. Date: Oct 2011, Lot: PA029HE1, Exp. Date: Nov 2012, Lot: PA069FP1, Exp. Date: Jun 2012, Lot: PA070FP1, Exp. Date: Jun 2012, Lot: PA102FD2, Exp. Oct 2011, Lot: PA101FD1, Exp. Date: Oct 2011, Lot: PA102FD1, Exp. Date: Oct 2011; 5) Lot PA071FP1 and PA072FP1, Exp. Date: Jun 2012; 6) Lot: 1105000465, Exp. Date: May 2013and Lot: 0911000100, Exp. Nov 2011; 7) Lot: PA010HH2, Exp. Date 2013, Lot: PA011HE3, Exp. Date: May 2013, Lot: PA012HC2, Exp. Date: Mar 2013, Lot: PA064FP1, Exp. Date: Dec 2012 and Lot PA087FB1, Exp. Date: Feb 2012; 8) Lot: PA038EP1, Exp. Date: Dec 2011, Lot: PA073FP1, Exp. Date: Dec 2012; Lot: PA073FP2, Exp. Date: Dec 2012; Lot: PA085FB1, Exp. Date: Feb 2012 and Lot: PA098HC1, Exp. Date: Mar 2013

Manufacturer:

GlaxoSmithKline Panama S.A., Panama, Panama, GlaxoSmithKline Costa Rica, S.A., San Jose, Costa Rica. Firm initiated recall is ongoing.

Recalled by:

GlaxoSmithKline Inc., Zebulon, NC, by letter on/about Oct. 6, 2011.

Distribution:

602,578 units; nationwide and Puerto Rico

Reason:

Current good manufacturing practices deviations: some of the analytical process validation activities did not contain primary data.

Recall number:

D-876/883-2012

DRUGS - CLASS III

Walgreen’s Children's Triple Acting Daytime Cold & Cough, 4 oz., batch # 213836, 215792, 215770, 215771

Lots: 50236, 50244, 50259, 50260

Manufacturer:

Aaron Industries Inc., Lynwood, CA

Recalled by:

Manufacturer, by letter dated Oct. 5, 2010. Firm-initiated recall is ongoing.

Distribution:

62,064 bottles; nationwide

Reason:

Labeling, label mix-up: product has a discrepancy for the indications on the principal display panel for the unit carton.

Recall number:

D-814-2012

The Magic Bullet (bisacodyl) suppository, 10 mg, a) 12-count suppositories per carton, NDC 57648-002-12; b) 100-count suppositories per carton, NDC 57648-002-01

Lots: a) 10101, Exp 07/11; 10201, Exp 08/11; 10306, Exp 09/11; 10504, Exp 11/11; 10703, Exp 01/12; b) 10101, 10106, Exp 07/11; 10201, Exp 08/11; 10305, 10306, Exp 09/11; 10403, Exp 10/11; 10504, Exp 11/11; 10602, Exp 12/11; 10703, Exp 01/12

Manufacturer:

Elge Inc., Rosenberg, TX

Recalled by:

Manufacturer, by letters dated July 26, 2011. Firm-initiated recall is ongoing.

Distribution:

20,254 cartons; nationwide

Reason:

Subpotent (single ingredient) drug: the product may not maintain its labeled potency throughout its expiration date.

Recall number:

D-858-2012

Red Hot Ointment (Oleoresin Capsicum), 4.95%, a) 2.75 ounces (78 g) tube, UPC 3 11960 04644 2, Stock No. 180522; b) 1 Lb (454 g) jar, UPC 3 11960 04614 5, Stock No. 180538.

Lot: LVC138, Exp 04/06/13

Manufacturer:

Cramer Products Inc., Gardner, KS

Recalled by:

Manufacturer, by letter on June 6, 2011. Firm-initiated recall is ongoing.

Distribution:

1,211 tubes and 564 jars; nationwide, Puerto Rico, Guam, Bermuda, Canada, Mexico, and Spain

Reason:

Subpotent (single ingredient) drug: the firm found low potency test results on stability samples of Red Hot Analgesic Ointment.

Recall number:

D-865-2012

1) Rite Aid Pharmacy, laxative saline enema, monobasic sodium phosphate 19 g, dibasic sodium phosphate 7 g, 4.5 Fl oz (133 mL) Each, 12 bottles per box, NDC 11822489080; 2) Premier Value, Complete Ready to use Enema, Sodium Phosphates Rectal Solution, 4.5 fl oz (133 mL) Each, 3 bottles per box, NDC 68016-0021-45

1) and 2) Lot Number 2021

Manufacturer:

Natureplex LLC, Memphis, TN

Recalled by:

Manufacturer, by telephone and letter on Oct. 18, 2011. Firm-initiated recall is ongoing.

Distribution:

3910 bottles; nationwide

Reason:

Super-potent (multiple ingredient) drug

Recall number:

D-870/871-2012

EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. 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 - violative product not likely to cause adverse health consequences.

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