Why it was recalled
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 100044259, Exp 06/30/2025.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0439-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 28, 2024
- FDA report date
- Apr 17, 2024
- Quantity
- 5,304 3x10-cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0439-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94294
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 100044259, Exp 06/30/2025.
- Postal code
- 07054-1120
- Report date
- Apr 17, 2024
- Product type
- Drugs
- Recall number
- D-0439-2024
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 5,304 3x10-cartons
- Reason for recall
- Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 28, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2024