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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 11261–11280 of 17,816 recalls

Class IITerminated

Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK

The Apothecary Shoppe LLC

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

September 12, 2016 · DrugView details →

Class IITerminated

Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX

MOORE'S COMPOUNDING PHARMACY

Superpotent Drug and Subpotent Drug; potency failures obtained

September 12, 2016 · DrugView details →

Class IITerminated

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

The Apothecary Shoppe LLC

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

September 12, 2016 · DrugView details →

Class IITerminated

Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

The Apothecary Shoppe LLC

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

September 12, 2016 · DrugView details →

Class IITerminated

Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002

Cadila Pharmaceuticals Limited

Microbial Contamination of Non-Sterile Product

September 9, 2016 · DrugView details →

Class IIITerminated

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

Pfizer Inc.

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

September 9, 2016 · DrugView details →

Class IIITerminated

Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10

Mckesson Packaging Services

Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

September 8, 2016 · DrugView details →

Class ITerminated

GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15

Novo Nordisk Inc

Defective delivery system: detached needles on the syringe in the kit.

September 8, 2016 · DrugView details →

Class IIITerminated

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

Biocompatibles U.K., Ltd.

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

September 7, 2016 · DrugView details →

Class IIITerminated

Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10

Shire

Presence of Foreign Tablets/Capsules

September 2, 2016 · DrugView details →

Class IITerminated

Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828

United Exchange Corporation

Lack of assurance of sterility

September 2, 2016 · DrugView details →

Class IITerminated

Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97

United Exchange Corporation

Lack of assurance of sterility

September 2, 2016 · DrugView details →

Class ITerminated

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

VIRTUS PHARMACEUTICALS OPCO II L

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

September 2, 2016 · DrugView details →

Class IITerminated

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

United Exchange Corporation

Lack of assurance of sterility

September 2, 2016 · DrugView details →

Class ITerminated

Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

VIRTUS PHARMACEUTICALS OPCO II L

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

September 2, 2016 · DrugView details →

Class ITerminated

EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

United Exchange Corporation

Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.

September 2, 2016 · DrugView details →

Class ITerminated

Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

VIRTUS PHARMACEUTICALS OPCO II L

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

September 2, 2016 · DrugView details →

Class IIITerminated

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

Sanofi-Aventis U.S. LLC

Labeling: Incorrect or Missing Package Insert

September 1, 2016 · DrugView details →

Class IIIOngoing

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

Actavis Laboratories, FL, Inc.

Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.

August 30, 2016 · DrugView details →

Class IIITerminated

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

August 29, 2016 · DrugView details →

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