Why it was recalled
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Product description
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
Lot numbers, UPCs & expiration codes
lot 29C220, Exp. 11/15
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-1538-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2014
- FDA report date
- Aug 20, 2014
- Quantity
- 3881bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1538-2014, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68522
- Address
- 1090 Horsham Rd
- Code information
- lot 29C220, Exp. 11/15
- Postal code
- 19454-1505
- Report date
- Aug 20, 2014
- Product type
- Drugs
- Recall number
- D-1538-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 3881bottles
- Termination date
- Dec 16, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 5, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2014