Drug recall D-1237-2020
Product
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots and codes
Lot #: 046180056A, Exp. Date 05/2020
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 14707 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 18, 2020
- Terminated
- March 25, 2024
Related products
- Oxycodone And Acetaminophen – drug information
- NDC 13107-045 Oxycodone and Acetaminophen · Oxycodone Hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Aurolife Pharma, LLC
- NDC 13107-046 Oxycodone and Acetaminophen · Oxycodone Hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Aurolife Pharma, LLC
- NDC 13107-043 Oxycodone and Acetaminophen · Oxycodone Hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 · Aurolife Pharma, LLC
- NDC 13107-044 Oxycodone and Acetaminophen · Oxycodone Hydrochloride 5 mg/1; Acetaminophen 325 mg/1 · Aurolife Pharma, LLC