Class I - Dangerous
Subpotent Drug: Drug potency was compromised during shipment.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
Caraco Pharmaceutical Laboratories
Class I - Dangerous
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Failed Tablet Specifications: Broken Tablets Present.
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Mylan Pharmaceuticals
Class I - Dangerous
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.
Watson Laboratories, Inc.-(Actavis) - Florida
Class I - Dangerous
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Class I - Dangerous
Failed Stability Testing: This product is below specification for preservative content.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Broken tablets
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
Teva Pharmaceuticals USA
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
Insight Instruments
Class I - Dangerous
Marketed without an Approved NDA/ANDA.
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specification; 12-Month stability interval.
Class I - Dangerous
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Class I - Dangerous
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Central Shared Services
Class I - Dangerous
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Fusion Pharmaceuticals
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33
Forest Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02
Baxter Healthcare
Class I - Dangerous
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.
Forest Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.