Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets Recalled by Prescript Pharmaceuticals, Inc. Due to Labeling: Not Elsewhere Classified: due to a labeled...

Date: April 24, 2018
Company: Prescript Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Prescript Pharmaceuticals, Inc. directly.

Affected Products

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

Quantity: 1 20-count containers

Why Was This 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).

Where Was This Sold?

California.

About Prescript Pharmaceuticals, Inc.

Prescript Pharmaceuticals, Inc. has 5 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report