FDA recall D-0439-2024

Product

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

Reason for recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-03-28

Report date

2024-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0439-2024