Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Lot numbers, UPCs & expiration codes
Lot #: 34025714A, Exp. Date 12/2016
Where it was sold
Nationwide
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-0005-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 5, 2016
- FDA report date
- Oct 12, 2016
- Quantity
- 3,569 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-0005-2017, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74842
- Address
- 425 Privet Rd
- Code information
- Lot #: 34025714A, Exp. Date 12/2016
- Postal code
- 19044-1220
- Report date
- Oct 12, 2016
- Product type
- Drugs
- Recall number
- D-0005-2017
- Classification
- Class III
- Recalling firm
- Teva North America
- Product quantity
- 3,569 capsules
- Termination date
- Mar 13, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 5, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2016