Drug product
Atropine Sulfate Injection in all strengths, all doses, and all packaging.
D-0456-2018
Product summary
- Event
- Event 78828
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0456-2018
Official wording
Reason: Lack of sterility assurance.
Code information: All lots remaining within expiry.
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility