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Precision Dose Inc. FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dosClass IIJul 14, 2026Failed Impurities/Degradation Specifications
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count Class IINov 1, 2021cGMP Deviations: Product manufactured with contaminated raw
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) Class IINov 1, 2021cGMP Deviations: Product manufactured with contaminated raw
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, Class IIJan 1, 2021cGMP deviations: The firm was notified of the manufacturer's

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