Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: FG01517, Exp. 12/31/2019
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mayne Pharma Inc
- Reason for Recall:
- Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Product Codes/Lot Numbers:
Lot: FG01517, Exp. 12/31/2019
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1129-2018
Related Recalls
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Product Mix-Up: A foreign tablet was found in bottle.