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Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup...

FDA Recall #D-0095-2022 — Class II — November 1, 2021

Recall #D-0095-2022 Date: November 1, 2021 Classification: Class II Status: Terminated

Product Description

Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

Reason for Recall

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Recalling Firm

Precision Dose Inc. — South Beloit, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

151,100 unit dose cups

Distribution

Nationwide USA

Code Information

Lot#: 503679, 503693, 503715

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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