FDA recall D-1049-2022
Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug
Product
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
Distribution
USA nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-13
- Report date
- 2022-06-15
- Termination date
- 2023-11-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Richmond, VA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2022