Recalls / Class II
Class IID-0998-2020
Product
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
- Affected lot / code info
- Lot: FG11514 Exp. 05/2021
Why it was recalled
Product Mix-Up: A foreign tablet was found in bottle.
Recalling firm
- Firm
- Mayne Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1240 Sugg Pkwy, Greenville, North Carolina 27834-9006
Distribution
- Quantity
- 8274 100-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-03-02
- FDA classified
- 2020-03-09
- Posted by FDA
- 2020-03-18
- Terminated
- 2021-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0998-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.