Class I - Dangerous
Subpotent Drug: Supplier indicated assay results did not meet specifications.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class I - Dangerous
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
AuroMedics Pharma
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class I - Dangerous
Discoloration: Product complaints of discoloration after reconstitution of vials.
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
SCA Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Amneal Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
AuroMedics Pharma
Class I - Dangerous
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,
Surgery Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective delivery system; product is not foaming or is coming out as liquid.
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Amneal Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
AuroMedics Pharma
Class I - Dangerous
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or expiration date.
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Amneal Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
Defective delivery system; product is not foaming or is coming out as liquid.
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409
Surgery Pharmacy Services
Class I - Dangerous
Lack of sterility assurance.
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: Presence of a foreign object in a single tablet.