FDA-Drug2026-04-15Class II
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Teva Pharmaceuticals USA, Inc
Hazard
Superpotent and Subpotent
Sold states
FL, OH, PR & MS
Affected count
8376 packages
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2026Original summary
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack). Superpotent and Subpotent Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 . Distribution: FL, OH, PR & MS Affected quantity: 8376 packages
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