DrugAug 12, 2015
GlaxoSmithkline Consmer Healthcare Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 recall — FDA D-1287-2015
Failed Dissolution Specifications
Class IIIFDA: TerminatedGlaxoSmithkline Consmer Healthcare
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 294
10,690 detailed records are currently available in this category.
DrugAug 12, 2015
The Apothecary Shoppe SIU-Papav/Phentol 30/.5 mg/mL Injection recall — FDA D-1299-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Papav/Phentol 30/1 mg/mL Injection recall — FDA D-1296-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIH-Testosterone Cyp. 20 mg/mL Injection recall — FDA D-1293-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Tri-Mix 20/1 mg/10 mcg/mL recall — FDA D-1306-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Tri-Mix 6/0.33/3.33 Injection Solution recall — FDA D-1304-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe S-Methylcobalamin 1000 mcg/mL (PF) Injection recall — FDA D-1289-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Papav/Phent 24/1 mg/mL Inj recall — FDA D-1295-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Prostaglandin E1 20 mcg/mL Injection recall — FDA D-1301-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Phentolamine 5 mg/mL in Normal Saline recall — FDA D-1314-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Phent .8/PGE1 20 mcg/mL Inj recall — FDA D-1300-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and recall — FDA D-1283-2015
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugAug 12, 2015
The Apothecary Shoppe S-methylcobalamin 25 mg/mL (PF) Injection recall — FDA D-1292-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIH-Testosterone Cyp. 200 mg/mL Injection recall — FDA D-1291-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Phent .4 mg/PGE1 20 mcg/mL Injection recall — FDA D-1297-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
The Apothecary Shoppe SIU-Papaverine 30 mg/mL Inj recall — FDA D-1294-2015
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class IIFDA: TerminatedThe Apothecary Shoppe LLC
DrugAug 12, 2015
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended recall — FDA D-1284-2015
Failed Dissolution Specifications
Class IIIFDA: TerminatedShionogi Inc.
DrugAug 5, 2015
Mutual Pharmaceutical Company Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE recall — FDA D-1282-2015
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class IIFDA: TerminatedMutual Pharmaceutical Company, Inc.
DrugAug 5, 2015
Mutual Pharmaceutical Company Clonidine Hydrochloride Tablets, USP, 0.1 mg recall — FDA D-1280-2015
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class IIFDA: TerminatedMutual Pharmaceutical Company, Inc.
DrugAug 5, 2015
Mutual Pharmaceutical Company Clonidine Hydrochloride Tablets, USP, 0.2 mg recall — FDA D-1281-2015
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class IIFDA: TerminatedMutual Pharmaceutical Company, Inc.
DrugAug 5, 2015
COMBIVENT RESPIMAT recall — FDA D-1279-2015
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class IIFDA: TerminatedBoehringer Ingelheim Roxane Inc.
DrugJul 29, 2015
Wockhardt Usa Famotodine Tablets, USP, 20 mg Tablets recall — FDA D-1265-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedWockhardt Usa Inc.
DrugJul 29, 2015
Wockhardt Usa Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only recall — FDA D-1266-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedWockhardt Usa Inc.
DrugJul 29, 2015
Wockhardt Usa Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles recall — FDA D-1249-2015
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class IIFDA: TerminatedWockhardt Usa Inc.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.