Recall Enforment Report D-0095-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Precision Dose Inc., originally initiated on 11-01-2021 for the product 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. The product was recalled due to cgmp deviations: product manufactured with contaminated raw ingredient.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0095-202211-01-202111-17-2021Class II151,100 unit dose cupsAcetaminophen 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.cGMP Deviations: Product manufactured with contaminated raw ingredient.Ongoing
D-0094-202211-01-202111-17-2021Class II166,920 unit dose cupsAcetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.cGMP Deviations: Product manufactured with contaminated raw ingredient.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68094-030Acetaminophen AcetaminophenSuspensionOralPrecision Dose, Inc.Human Otc Drug
68094-231Acetaminophen AcetaminophenSuspensionOralPrecision Dose, Inc.Human Otc Drug
68094-330Acetaminophen AcetaminophenSuspensionOralPrecision Dose, Inc.Human Otc Drug