FDAFDA · Food and drugs·Recall number D-0806-2018
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Published May 23, 2018 · Recall initiated: April 24, 2018
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
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Manufacturer
- Prescript Pharmaceuticals, Inc.
- Distributor
- California.
- UPC
- 0313107058011
- Lot
- Lot # 0130131, EXP 8/31/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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