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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 12681–12700 of 17,816 recalls

Class IIITerminated

METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.

Golden State Medical Supply Inc.

Presence of Foreign Substance: Presence of hair.

August 11, 2015 · DrugView details →

Class ITerminated

KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC

Blue Square Market, Inc.

Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.

August 6, 2015 · DrugView details →

Class IITerminated

DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144.

3M Company - Health Care Business

Chemical contamination: Product may be contaminated with a toxic compound.

August 6, 2015 · DrugView details →

Class ITerminated

LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd

Blue Square Market, Inc.

Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

August 6, 2015 · DrugView details →

Class IIITerminated

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.

Taro Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

August 5, 2015 · DrugView details →

Class IITerminated

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

August 3, 2015 · DrugView details →

Class IITerminated

Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10

Unichem Pharmaceuticals Usa Inc

Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

July 30, 2015 · DrugView details →

Class IITerminated

Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Failed Dissolution Specifications

July 29, 2015 · DrugView details →

Class IITerminated

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

Wockhardt Usa Inc.

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

July 29, 2015 · DrugView details →

Class IITerminated

Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.

Wockhardt Usa Inc.

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

July 29, 2015 · DrugView details →

Class IIITerminated

Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

Fresenius Kabi USA, LLC

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

July 28, 2015 · DrugView details →

Class IIITerminated

Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

Class IIITerminated

Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

July 28, 2015 · DrugView details →

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