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
Reported: September 29, 2021 Initiated: July 29, 2021 #D-0806-2021
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
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 1,632 cartons
- Distribution
- CO, FL, MO, OH
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group. Units affected: 1,632 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0806-2021.
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