Recalls / Class II
Class IID-0806-2021
Product
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
- Brand name
- Entacapone
- Generic name
- Entacapone
- Active ingredient
- Entacapone
- Route
- Oral
- NDC
- 0904-6822
- FDA application
- ANDA203437
- Affected lot / code info
- Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 1,632 cartons
- Distribution pattern
- CO, FL, MO, OH
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-09-17
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0806-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.