CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Losartan 50mg Tablet, 30 count each blister card.
RemedyRepack
Class I - Dangerous
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Aurobindo Pharma USA
Class I - Dangerous
Presence of Particulate Matter: One vial was found to contain a hair.
Class I - Dangerous
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Health Solutions Pharmacy Center Inc
Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class I - Dangerous
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
X-Gen Pharmaceuticals
Class I - Dangerous
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
H J Harkins Company Inc
Class I - Dangerous
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Health Solutions Pharmacy Center Inc
Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Auro Pharmacies Inc.
Class I - Dangerous
Failed pH Specification: product does not meet pH label claim.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.