Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date.
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Superpotent Drug: High out of specification assay value results for potency.
Class I - Dangerous
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
ICU Medical
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Class I - Dangerous
Lack of assurance of sterility: Bags have potential to leak.
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Mylan Pharmaceuticals
Class I - Dangerous
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class I - Dangerous
Contraceptive Tablets Out of Sequence.
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
PharMEDium Services
Class I - Dangerous
Superpotent and Subpotent
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Pharmaceutical Associates
Class I - Dangerous
Resuspension problems: Out of specification for appearance and resuspendability.
Presence of foreign substance: glass particles
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
HOSPIRA INC, LAKE FOREST
Class I - Dangerous
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Shoreside Enterprises
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.