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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 941–960 of 1,000 recalls

Class IIITerminated

Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).

Pfizer Inc

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

March 7, 2017 · DrugView details →

Class IIITerminated

Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Indian God Lotion Spray Bottle, labeling is in foreign language

A&H Focal Inc.

Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

March 7, 2017 · DrugView details →

Class IIITerminated

Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10).

Pfizer Inc

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

March 7, 2017 · DrugView details →

Class IIITerminated

Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).

Pfizer Inc

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

March 7, 2017 · DrugView details →

Class IIITerminated

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

March 7, 2017 · DrugView details →

Class IIITerminated

RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60

Dr. Reddy's Laboratories, Inc.

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

March 6, 2017 · DrugView details →

Class IIITerminated

Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.

G & W Laboratories, Inc.

CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

February 28, 2017 · DrugView details →

Class IIITerminated

Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99

Citron Pharma Llc

Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

February 24, 2017 · DrugView details →

Class IIITerminated

Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60

Novel Laboratories, Inc.

Chemical Contamination

February 22, 2017 · DrugView details →

Class IIITerminated

A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981

Bayer HealthCare Pharmaceuticals, Inc.

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

February 21, 2017 · DrugView details →

Class IIITerminated

Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services, LLC

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

February 17, 2017 · DrugView details →

Class IIITerminated

Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Pharmedium Services, LLC

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

February 17, 2017 · DrugView details →

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