Recalls / Class II
Class IID-0806-2018
Product
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
- 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 # 0130131, EXP 8/31/20
Why it was recalled
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).
Recalling firm
- Firm
- Prescript Pharmaceuticals, Inc.
- Manufacturer
- Aurolife Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 39 California Ave Ste 104, Pleasanton, California 94566-6279
Distribution
- Quantity
- 1 20-count containers
- Distribution pattern
- California.
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-14
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0806-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.