Drug product
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
D-0551-2018
Product summary
- Event
- Event 78541
- Status
- Terminated
- Classification
- Class I
- Quantity
- 60,000 bottles
- Official record key
drug-enforcement:D-0551-2018
Official wording
Reason: Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Code information: Lot #: 86041601, Exp 09/19
Distribution pattern: Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Derived failure modes
-
Microbial contamination
microbial contamination