Precision Dose glycopyrrolate oral solution recalled for unidentified 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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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).
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 722 Progressive Ln, N/A, South Beloit, IL, United States
- Classification
- Not Yet Classified
- Recall number
- 99388
In the FDA's words
- Description
- 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). Due to an out-of-specification result for an unidentified impurity detected during routine stability testing. Lot # 506033, Exp Date: 11/30/2026. Distribution: US Nationwide. Affected quantity: N/A
- Hazard
- Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.