Drug product
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
D-0042-2015
Product summary
- Event
- Event 68375
- Status
- Terminated
- Classification
- Class II
- Quantity
- 531 bottles
- Official record key
drug-enforcement:D-0042-2015
Official wording
Reason: Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Code information: Lot 39661-3 Exp. 07/15
Distribution pattern: Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets