Recalls / Class II
Class IID-0042-2015
Product
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
- Affected lot / code info
- Lot 39661-3 Exp. 07/15
Why it was recalled
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave Ste B, Corona, California 92880-6920
Distribution
- Quantity
- 531 bottles
- Distribution pattern
- Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Timeline
- Recall initiated
- 2014-05-22
- FDA classified
- 2014-10-23
- Posted by FDA
- 2014-10-29
- Terminated
- 2014-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0042-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.