Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Defective Container: Repetitive complaints received indicating pump not working.
Class I - Dangerous
Lack of assurance of sterility: loss of container integrity.
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Heritage Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class I - Dangerous
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Upsher Smith Laboratories
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Presence of precipitate
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Upsher Smith Laboratories
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I - Dangerous
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.