Recalls / Class II
Class IID-66403-004
Product
Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
- Affected lot / code info
- Lot #: 3032075, 3032076
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 521 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-09-13
- FDA classified
- 2013-11-04
- Posted by FDA
- 2013-11-13
- Terminated
- 2015-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66403-004. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.