The Recall Desk
ModerateFDA (Drugs)·D-0806-2018·Announced 2018-05-23

Prescript Pharmaceuticals Recalls Acetaminophen and Codeine Tablets for Labeling Error

Prescript Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because the storage temperature instructions on the label differ from the original manufacturer's declaration.

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 and involves a minor labeling error regarding storage temperatures, which fits the rubric for moderate severity.

Plain-English summary

Prescript Pharmaceuticals, Inc. is recalling one 20-count container of Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP. The affected product is identified by Lot # 0130131 and an expiration date of 8/31/20. The product was distributed in California.

The recall was initiated due to a labeling error. The product label declares storage instructions of "Store at 15°C to 30°C (59°F to 86°F)," which differs from the original manufacturer's declaration of "Store at 20°C to 25°C (68°F to 77°F)."

Consumers who have this specific product should contact their pharmacist or healthcare provider for guidance on whether to continue using the medication or to return it for a replacement.

The recalled product

Product
ACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN AND CODEINE PHOSPHATE)
Brand
ACETAMINOPHEN AND CODEINE PHOSPHATE

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 (2)

  • Lot # 0130131
  • EXP 8/31/20

UPCs (1)

  • 0313107058011

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.

See all 5 products in this recall →

Same brand · ACETAMINOPHEN AND CODEINE PHOSPHATE