Recalls / Class II
Class IID-1354-2014
Product
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
- Affected lot / code info
- 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units
Why it was recalled
Non-sterility: due to a failed sterility test
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 47890
- Distribution pattern
- NY and KY
Timeline
- Recall initiated
- 2014-03-21
- FDA classified
- 2014-05-28
- Posted by FDA
- 2014-06-04
- Terminated
- 2014-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1354-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.