Recalls / Class II
Class IID-1231-2020
Product
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
- Brand name
- Acetaminophen And Codeine Phosphate
- Generic name
- Acetaminophen And Codeine Phosphate
- Active ingredients
- Acetaminophen, Codeine Phosphate
- Route
- Oral
- NDCs
- 13107-058, 13107-059, 13107-060
- FDA application
- ANDA202800
- Affected lot / code info
- Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurolife Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 57337 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-18
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1231-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.