Prescript Pharmaceuticals Recalls Acetaminophen with Codeine Tablets for Labeling Error
Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets due to a storage temperature labeling discrepancy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a minor labeling error regarding storage temperature, which fits the rubric for moderate severity involving minor labeling issues.
Plain-English summary
Prescript Pharmaceuticals, Inc. is recalling Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers. The recall is due to a labeling error where the product is declared to be stored at 15°C to 30°C (59°F to 86°F), which differs from the original manufacturer's declaration of 20°C to 25°C (68°F to 77°F).
The affected product is manufactured for Mallinckrodt Inc. and packaged by PreScript Pharm Inc. The specific lot number is 0130130 with an expiration date of 12/31/20. The NDC is 00406-0484-10. The distribution pattern is listed as California.
Consumers and healthcare providers should check their inventory for this specific lot and NDC. If found, the product should be returned to the pharmacy or distributor for credit. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 007
- Manufacturer
- Prescript Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 0130130 EXP 12/31/20
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Prescript Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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