FDA-Drug2026-07-29Not Yet ClassifiedCHEMICAL
Precision Dose glycopyrrolate oral solution recalled for unidentified impurity
OTHERNationwide distribution
Precision Dose glycopyrrolate solution recalled for impurity
Precision Dose Inc. is recalling one lot of Glycopyrrolate Oral Solution (1 mg/5 mL) due to an unidentified impurity found during routine stability testing that does not meet specification. The affected lot (506033) expires November 30, 2026. This medication is prescription-only and supplied in unit-dose oral syringes.
- Check if you have lot 506033 of this medication (expiration 11/30/2026).
- Contact your pharmacy or prescriber if you have this lot.
- Do not use the product; return it to your pharmacy.
Hazard
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=99388Don't want to check this manually?
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