Why it was recalled
Failed Dissolution Specifications
Product description
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
Lot numbers, UPCs & expiration codes
Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
Where it was sold
CO, FL, MO, OH
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-0806-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 1,632 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0806-2021, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 88638
- Address
- 17187 N Laurel Park Dr Ste 300
- Code information
- Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
- Postal code
- 48152-2600
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0806-2021
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 1,632 cartons
- Termination date
- Feb 19, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
- Distribution pattern
- CO, FL, MO, OH
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2021