Recalls / Class III
Class IIID-0005-2017
Product
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
- Affected lot / code info
- Lot #: 34025714A, Exp. Date 12/2016
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 3,569 capsules
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-05
- FDA classified
- 2016-10-05
- Posted by FDA
- 2016-10-12
- Terminated
- 2017-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.