Class I - Dangerous
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
CGMP Deviations
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Homeocare Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class I - Dangerous
Failed Impurities/Degradation Specifications
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Failed Dissolution Specifications: results below specifications
Class I - Dangerous
Cross contamination with other products.
Class I - Dangerous
Cross contamination with other products.
Class I - Dangerous
Cross contamination with other products
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Rising Pharma Holding
Class I - Dangerous
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class I - Dangerous
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
Zydus Pharmaceuticals (USA)
Class I - Dangerous
Cross contamination with other products
Class I - Dangerous
Subpotent Drug: reduced efficacy for epinephrine
Class I - Dangerous
Subpotent drug: out of specification results
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of foreign substance.
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Trigen Laboratories
Class I - Dangerous
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class I - Dangerous
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class I - Dangerous
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.