Drug product
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01
D-220-2013
Product summary
- Event
- Event 64100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,136 units
- Official record key
drug-enforcement:D-220-2013
Official wording
Reason: Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Code information: Lot #: CB222A, Exp 06/16
Distribution pattern: GA, AR
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance