Recalls / Class II
Class IID-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
- Brand name
- Isotretinoin
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436
- FDA application
- ANDA205063
- Affected lot / code info
- Lot #: 100044259, Exp 06/30/2025.
Why it was recalled
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 5,304 3x10-cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-28
- FDA classified
- 2024-04-08
- Posted by FDA
- 2024-04-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0439-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.