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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 6101–6120 of 17,773 recalls

Class IITerminated

Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.

Sun Pharmaceutical Industries, Inc.

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

March 13, 2020 · DrugView details →
Class IITerminated

C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.

Medical Center Pharmacy, Inc.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

March 13, 2020 · DrugView details →
Class IITerminated

*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.

Medical Center Pharmacy, Inc.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

March 13, 2020 · DrugView details →
Class IITerminated

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.

Sun Pharmaceutical Industries, Inc.

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

March 13, 2020 · DrugView details →
Class IITerminated

C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.

Medical Center Pharmacy, Inc.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

March 13, 2020 · DrugView details →
Class IITerminated

C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.

Medical Center Pharmacy, Inc.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

March 13, 2020 · DrugView details →
Class IITerminated

*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.

Medical Center Pharmacy, Inc.

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

March 13, 2020 · DrugView details →
Class IITerminated

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

Jubilant Cadista Pharmaceuticals, Inc.

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

March 11, 2020 · DrugView details →
Class IITerminated

Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

Matthew 7:25 Inc dba Thrive Pharmacy

Subpotent Drug

March 10, 2020 · DrugView details →
Class IITerminated

Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

Matthew 7:25 Inc dba Thrive Pharmacy

Subpotent Drug

March 10, 2020 · DrugView details →
Class IITerminated

Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

Matthew 7:25 Inc dba Thrive Pharmacy

Subpotent Drug

March 10, 2020 · DrugView details →
Class IITerminated

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

Mylan Pharmaceuticals Inc.

Presence of particulate matter. presence of metal particles.

March 9, 2020 · DrugView details →
Class IITerminated

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

Lupin Pharmaceuticals Inc.

Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

March 9, 2020 · DrugView details →
Class IIITerminated

Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

Lupin Pharmaceuticals Inc.

Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.

March 9, 2020 · DrugView details →
Class IITerminated

Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05

Sun Pharmaceutical Industries, Inc.

Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.

March 9, 2020 · DrugView details →
Class IITerminated

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.

Nostrum Laboratories Inc

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

March 6, 2020 · DrugView details →
Class IITerminated

Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433

H J Harkins Company Inc dba Pharma Pac

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle

March 6, 2020 · DrugView details →
Class IITerminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

Fresenius Medical Care Holdings, Inc.

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

March 5, 2020 · DrugView details →
Class IITerminated

Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

Teva Pharmaceuticals USA

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

March 5, 2020 · DrugView details →
Class IIITerminated

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31

Par Pharmaceutical Inc.

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

March 4, 2020 · DrugView details →
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