PlainRecalls
FDA Drug Moderate Class II Terminated

Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1049-2022

Product Description

Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
1 carton/4 bottles per carton/25 tablets per bottle
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 carton/4 bottles per carton/25 tablets per bottle.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1049-2022.