Advanced Pharma Recalls Ofirmev Injection Due to Latex Labeling
Advanced Pharma Inc. is recalling Ofirmev (Acetaminophen) injection because the product may contain synthetic or natural latex, which is not currently classified in the labeling.
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, which typically corresponds to a Moderate severity score under the rubric, particularly for labeling issues that may cause temporary or medically reversible health consequences.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Ofirmev (Acetaminophen) injection in all strengths, dosage forms, and packaging. The recall is being conducted because the product may contain synthetic latex and/or natural latex, a condition that is not currently classified in the product's labeling.
The recall covers all lots of the medication, which is distributed nationwide in the United States. Ofirmev is a prescription-only medication manufactured by Advanced Pharma Inc. and distributed by Avella of Houston.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injection
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)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma 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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