Recalls / Class II
Class IID-0432-2023
Product
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
- Affected lot / code info
- Lot: M04145 Exp. 01/2024
Why it was recalled
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 17,586 cartons
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-23
- FDA classified
- 2023-03-02
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0432-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.