FDA Recalls NDC 13107-060 Acetaminophen And Codeine Phosphate
Tablet Oral

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Acetaminophen And Codeine Phosphate with NDC 13107-060 was initiated on 03-18-2020 as a Class II recall due to cgmp deviations: products were manufactured in a processing area in which water leakage was observed The latest recall number for this product is D-1231-2020 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1231-202003-18-202004-22-2020Class II57337 unitsAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01Ongoing
D-1230-202003-18-202004-22-2020Class II4332 unitsAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99Ongoing
D-1229-202003-18-202004-22-2020Class II14194 unitsAcetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01Ongoing
D-0806-201804-24-201805-23-2018Class II1 20-count containersAcetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.