Drug product
Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
D-1048-2018
Product summary
- Event
- Event 80614
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,000 bottles
- Official record key
drug-enforcement:D-1048-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: a) 20171210, Exp. 12/2022; b) 20171210, Exp. 12/2022
Distribution pattern: NY and CA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations