Drug product
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
D-1322-2022
Product summary
- Event
- Event 90553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Jar
- Official record key
drug-enforcement:D-1322-2022
Official wording
Reason: CGMP Deviations: products were stored outside the drug label specifications.
Code information: Unavailable
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations