Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Reported: April 22, 2020 Initiated: March 18, 2020 #D-1230-2020
Product Description
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Reason for Recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 4332 units
- Distribution
- Nationwide within the United States
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99. Recalled by Aurobindo Pharma USA Inc.. Units affected: 4332 units.
Why was this product recalled? ▼
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 22, 2020. Severity: Moderate. Recall number: D-1230-2020.
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