Why it was recalled
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: M04145 Exp. 01/2024
Where it was sold
Distributed 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-0432-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 23, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 17,586 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0432-2023, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 91751
- Address
- 341 Mason Rd
- Code information
- Lot: M04145 Exp. 01/2024
- Postal code
- 37086-3606
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0432-2023
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 17,586 cartons
- Termination date
- Apr 30, 2024
- Reason for recall
- Packaging defect: observed packaging defect, blister packaging inadequately sealed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Feb 23, 2023
- Center classification date
- Mar 2, 2023