Class III
Terminated
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
This recall has been terminated (originally issued October 12, 2016).
- Company
- Teva North America
- Recall Initiated
- August 5, 2016
- Posted
- October 12, 2016
- Recall Number
- D-0005-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,569 capsules
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
Nationwide
Lot / Code Info
Lot #: 34025714A, Exp. Date 12/2016
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