Glycopyrrolate Injection
Reason Presence of Particulate Matter: Hair was found in product
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications
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).
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Particulate Matter: Hair was found in product
Reason Failed Impurities/Degradation Specifications
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Labeling: Label Mix-up
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