May 11, 2022DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Dist
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
May 11, 2022DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only,
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
May 11, 2022DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Pa
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
May 11, 2022DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
May 11, 2022DrugsFDA
McKesson Corporation dba McKesson Drug Company recalls Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 0
Hazard: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
May 11, 2022DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pha
Hazard: Failed viscosity specification - product was below specificcation
May 11, 2022DrugsFDA
Viatris Inc recalls alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 079
Hazard: Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-c
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-cou
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-co
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-0
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-0
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-co
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-coun
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-cou
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-1
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
SCA Pharmaceuticals recalls Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-092
Hazard: CGMP Deviations
May 11, 2022DrugsFDA
SCA Pharmaceuticals recalls Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06
Hazard: CGMP Deviations
May 11, 2022DrugsFDA
SCA Pharmaceuticals recalls Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Hazard: CGMP Deviations
May 4, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside
Hazard: Labeling: Missing label on the vial
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olymp
Hazard: Failed Reconstitution time
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convo
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orland
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia P
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Mult
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Mu
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
May 4, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 328
Hazard: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated