Teva North America recalls Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsu…
- Recall date
- August 5, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0005-2017
- FDA classification
- Class III
- Brand / firm
- Teva North America
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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