Class II · Moderate risk Ongoing
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials…
Reason Presence of Particulate Matter: Hair was found in product
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
What was recalled
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
- Recalling firm
- Pharmakon Pharmaceuticals
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1567-2014
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.
Other Glycopyrrolate recalls
See all
Class II · Moderate risk Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Terminated
glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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