Why it was recalled
Product Mix-Up: A foreign tablet was found in bottle.
Product description
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Lot numbers, UPCs & expiration codes
Lot: FG11514 Exp. 05/2021
Where it was sold
Distributed Nationwide in the USA
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-0998-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2020
- FDA report date
- Mar 18, 2020
- Quantity
- 8274 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Inc
Original FDA data
Every field from FDA enforcement report D-0998-2020, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 85125
- Address
- 1240 Sugg Pkwy
- Code information
- Lot: FG11514 Exp. 05/2021
- Postal code
- 27834-9006
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-0998-2020
- Classification
- Class II
- Recalling firm
- Mayne Pharma Inc
- Product quantity
- 8274 100-count bottles
- Termination date
- Oct 28, 2021
- Reason for recall
- Product Mix-Up: A foreign tablet was found in bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2020