Recalls / Class II
Class IID-1538-2014
Product
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
- Affected lot / code info
- lot 29C220, Exp. 11/15
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 3881bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-05
- FDA classified
- 2014-08-13
- Posted by FDA
- 2014-08-20
- Terminated
- 2014-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1538-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.