April 13, 2022DrugsFDA
Pfizer Inc. recalls Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis,
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack,
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC,
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, P
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-D
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Da
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Pfizer Inc. recalls Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Park
Hazard: CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
April 13, 2022DrugsFDA
Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,
Hazard: CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
April 13, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. S
Hazard: Subpotent
April 13, 2022DrugsFDA
Revive Personal Products Company recalls The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Pro
Hazard: Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
April 13, 2022DrugsFDA
DASH Pharmaceuticals LLC recalls Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 ca
Hazard: Labeling: Label Mix-Up
April 13, 2022DrugsFDA
Mylan Pharmaceuticals Inc recalls Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
April 13, 2022DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with l
Hazard: Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
April 13, 2022DrugsFDA
MERCK SHARP & DOHME CORP recalls Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sampl
Hazard: Presence of foreign substance: Presence of stainless steel particulates in tablets.
April 13, 2022DrugsFDA
The Ritedose Corporation recalls 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourci
Hazard: Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 725
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufacture
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 6, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured
Hazard: Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
April 6, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories L
Hazard: Failed Dissolution Specifications; during long term stability testing.
April 6, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-39
Hazard: Failed Dissolution Specifications; during long term stability testing.
April 6, 2022DrugsFDA
Aurolife Pharma, LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-
Hazard: Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Phar
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formul
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 1156
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML For
Hazard: Lack of sterility assurance.