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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 9381–9400 of 17,793 recalls

Class IIITerminated

Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02

Sun Pharmaceutical Industries, Inc.

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

April 26, 2018 · DrugView details →
Class IITerminated

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033

Prescript Pharmaceuticals, Inc.

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

April 24, 2018 · DrugView details →
Class IITerminated

Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834

Prescript Pharmaceuticals, Inc.

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

April 24, 2018 · DrugView details →
Class IITerminated

Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

Mylan Pharmaceuticals Inc.

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

April 24, 2018 · DrugView details →
Class IITerminated

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

Mylan Pharmaceuticals Inc.

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

April 24, 2018 · DrugView details →
Class IITerminated

Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482

Prescript Pharmaceuticals, Inc.

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

April 24, 2018 · DrugView details →
Class IITerminated

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

Mylan Pharmaceuticals Inc.

CGMP Deviations

April 24, 2018 · DrugView details →
Class IITerminated

Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176

Prescript Pharmaceuticals, Inc.

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

April 24, 2018 · DrugView details →
Class IITerminated

Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

Mylan Pharmaceuticals Inc.

CGMP Deviations

April 24, 2018 · DrugView details →
Class IITerminated

Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc

Vitalab Pharmacy, Inc

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

April 24, 2018 · DrugView details →
Class IITerminated

Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11

Prescript Pharmaceuticals, Inc.

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

April 24, 2018 · DrugView details →
Class IIITerminated

Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →
Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →
Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01

Dr. Reddy's Laboratories, Inc.

Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.

April 23, 2018 · DrugView details →
Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10

Mckesson Packaging Services

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

April 23, 2018 · DrugView details →
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