D-0998-2020 Class II Terminated
FDA drug recall D-0998-2020 was initiated by Mayne Pharma Inc on March 2, 2020 and is designated Class II. Reason for recall: Product Mix-Up: A foreign tablet was found in bottle. The recall status is terminated (terminated October 28, 2021). Affected quantity: 8274 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 18, 2020
- Initiation Date
- March 2, 2020
- Termination Date
- October 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8274 100-count bottles
Product Description
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Reason for Recall
Product Mix-Up: A foreign tablet was found in bottle.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot: FG11514 Exp. 05/2021