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).
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 0130131, EXP 8/31/20
Where it was sold
California.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0806-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2018
- FDA report date
- May 23, 2018
- Quantity
- 1 20-count containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prescript Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0806-2018, exactly as published.
Show all FDA fields
- City
- Pleasanton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79961
- Address
- 39 California Ave Ste 104
- Code information
- Lot # 0130131, EXP 8/31/20
- Postal code
- 94566-6279
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0806-2018
- Classification
- Class II
- Recalling firm
- Prescript Pharmaceuticals, Inc.
- Product quantity
- 1 20-count containers
- Termination date
- Jan 23, 2019
- Reason for recall
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- California.
- Recall initiation date
- Apr 24, 2018
- Initial firm notification
- Letter
- Center classification date
- May 14, 2018