Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville...

FDA Drug Recall #D-0998-2020 — Class II — March 2, 2020

Recall Summary

Recall Number D-0998-2020
Classification Class II — Moderate risk
Date Initiated March 2, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mayne Pharma Inc
Location Greenville, NC
Product Type Drugs
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

Lot / Code Information

Lot: FG11514 Exp. 05/2021

Other Recalls from Mayne Pharma Inc

Recall # Classification Product Date
D-1152-2022 Class II Clonidine Transdermal System, USP 0.3 mg/day, 4... Jun 9, 2022
D-0387-2022 Class II Lexette (halobetasol propionate) Topical Foam, ... Jan 14, 2022
D-1129-2018 Class III Oxycodone and Acetaminophen Tablets, USP, 5 mg*... Aug 21, 2018
D-0616-2018 Class III Fabior (tazarotene) Foam, 0.1%, 100 grams can, ... Mar 21, 2018
D-0098-2018 Class II Liothyronine Sodium Tablets, USP 25 mcg ,100-co... Nov 9, 2017

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.