FDAFDA · Food and drugs·Recall number D-1229-2020
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Published April 22, 2020 · Recall initiated: March 18, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0313107058011
- Lot
- Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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