FDA-Drug2020-04-22Class II
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
Aurobindo Pharma USA Inc.
Hazard
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Sold states
Nationwide within the United States
Affected count
57337 units
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1231-2020Don't want to check this manually?
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