RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
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PRODUCT
Atenolol and Chlorthalidone tablets, USP, 50/25 mg, bottles of 100, Rx only, NDC 0904-7881-60, Recall # D-158-2008
CODE
Lot L-1456, Exp. 08-09
RECALLING FIRM/MANUFACTURER
Legacy Pharmaceutical Packaging LLC, Earth City, MO, by letter on March 14, 2008. Firm initiated recall is ongoing.
REASON
Mislabeled; bottles labeled as Atenolo/Chlorthalidone Tablets 50mg/25mg actually contain Gabapentin 100 mg.
VOLUME OF PRODUCT IN COMMERCE
4,778/100-tablet bottles
DISTRIBUTION
MI
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PRODUCT
Etomidate Injection 20mg (2mg/mL), Sterile, nonpyrogenic, 10mL Single-Dose Vials, packaged in cartons of 10 vials, --- NDC 55390-762-10, Recall # D-200-2008
CODE
Lot #957881, Exp. Date 06/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH, by letters on March 24, 2008.
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Subpotent; 12month stability
VOLUME OF PRODUCT IN COMMERCE
97,290 20mg/10mL vials
DISTRIBUTION
Nationwide
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PRODUCT
Carbamazepine Tablets USP (Chewable), 100 mg, Rx, in bottles of 100 Tablets, NDC 51672-4041-1, and 500 Tablets, NDC 51672-4041-2, Recall # D-201-2008
CODE
Lots 078198, 078335, 078336 (exp. 7/2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letters on March 28, 2008.
Manufacturer: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel, Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirement.
VOLUME OF PRODUCT IN COMMERCE
26,008 bottles
DISTRIBUTION
Nationwide and Puerto Rico
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PRODUCT
Red Yeast Rice, Dietary Supplement, 600 mg potency, 60-capsule bottles, UPC 033674155172 and 120-capsule bottles, UPC 033674155400, Recall # D-202-2008
CODE
60-Capsule Bottles: Lots 509859, exp. 10/31/08; 514596, exp. 1/31/09; 522011, exp. 5/31/09; 528163, exp. 10/31/09; 530491, exp. 11/30/09; 120-Capsule Bottles: Lots 504570, exp. 6/30/08; 507169, exp. 8/31/08; 511280, exp. 10/31/08; 514341, exp. 1/31/09; 518847, exp. 1/31/09; 520928, exp. 4/30/09; 524941, exp. 8/31/09; 525251, exp. 8/31/09; 528162, exp. 10/31/09; 531608, exp. 11/30/09
RECALLING FIRM/MANUFACTURER
Nature's Way Products Inc., Springville Utah, by letter on March 31, 2008. FDA initiated recall is ongoing.
REASON
Product contains excessive levels of lovastatin.
VOLUME OF PRODUCT IN COMMERCE
74,859 bottles
DISTRIBUTION
Nationwide