Reported Oct 12, 2016 · Terminated
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30…
Teva North America
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva North America · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- 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
- Lot codes and dates
Lot #: 34025714AExp. Date 12/2016
- Amount recalled
- 3,569 capsules
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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