FDARecalled Apr 29, 2026 · #D-0521-2026
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pa...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Classification: Class II Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands
Product details
- Product
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Type
- Drugs
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Model numbers
- —
- UPCs
- —