FDA-Drug2024-04-17Class II
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Hazard
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Sold states
Nationwide in the USA
Affected count
5,304 3x10-cartons
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0439-2024More Teva Pharmaceuticals USA, Inc recalls
- FDA-Drug2026-04-29Teva Claravis (isotretinoin) 10 mg recalled for elevated tretinoin impurity levels
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.2 mg/day recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.1 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.3 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Isotretinoin 40 mg capsules recalled for inconsistent strength
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