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. Preci

FDA recall notice · announced November 17, 2021 · Precision Dose

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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.

Reason for recall

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Notes

Distribution: Nationwide USA
Lot/code information: Lot#: 503679, 503693, 503715
Quantity: 151,100 unit dose cups
Status: Terminated
Products in this recall event:
- Acetaminophen 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 cas (D-0094-2022)
- 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-c (D-0095-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.