| Mar 20, 2023 |
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepac... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 20, 2023 |
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03)... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 20, 2023 |
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-0... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 20, 2023 |
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 20, 2023 |
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 20, 2023 |
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01... |
cGMP Deviations |
Class II |
RemedyRepack Inc. |
| Mar 17, 2023 |
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 6800... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
Amerisource Health Services LLC |
| Mar 17, 2023 |
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 6... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
Amerisource Health Services LLC |
| Mar 17, 2023 |
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 680... |
CGMP Deviations: recalling drug products following an FDA inspection. |
Class II |
Amerisource Health Services LLC |
| Mar 16, 2023 |
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northw... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northw... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackag... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repac... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 16, 2023 |
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-8... |
CGMP Deviations |
Class II |
Northwind Pharmaceuticals LLC |
| Mar 14, 2023 |
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx ... |
CGMP Deviations: Discoloration |
Class II |
Hetero USA Inc |
| Mar 14, 2023 |
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... |
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... |
Class II |
Ascend Laboratories, LLC |
| Mar 14, 2023 |
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... |
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... |
Class II |
Ascend Laboratories, LLC |
| Mar 13, 2023 |
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-c... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, N... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 13, 2023 |
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... |
cGMP deviations |
Class II |
Direct Rx |
| Mar 2, 2023 |
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 |
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 |
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 |
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 |
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 |
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... |
CGMP Deviations: Potential risk of Cross Contamination |
Class II |
Breckenridge Pharmaceutical, Inc |
| Feb 24, 2023 |
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 24, 2023 |
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... |
CGMP DEVIATIONS |
Class II |
Ecometics, Inc. |
| Feb 23, 2023 |
NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid D... |
CGMP Deviations: Raw material recalled by repackager, due to discoloration. |
Class II |
Nutraceutical Corporation |
| Feb 23, 2023 |
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), ... |
CGMP Deviations: Raw material recalled by repackager, due to discoloration. |
Class II |
Nutraceutical Corporation |
| Feb 23, 2023 |
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ... |
CGMP Deviations: Raw material recalled by repackager, due to discoloration. |
Class II |
Nutraceutical Corporation |
| Feb 23, 2023 |
NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% A... |
CGMP Deviations: Raw material recalled by repackager, due to discoloration. |
Class II |
Nutraceutical Corporation |
| Feb 23, 2023 |
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... |
CGMP Deviations: Potential product carryover. |
Class II |
Nephron Sc Inc |
| Feb 22, 2023 |
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... |
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... |
Class II |
Teva Pharmaceuticals USA Inc |
| Feb 21, 2023 |
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... |
CGMP DEVIATIONS |
Class II |
Denver Solutions, LLC DBA Leiters Health |