Recalls / Class III
Class IIID-0853-2020
Product
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20.
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Intramuscular, Intravenous
- NDCs
- 55150-292, 55150-293, 55150-294, 55150-295
- FDA application
- ANDA210244
- Affected lot / code info
- Lot #CGP190001-A, Exp. 07/31/2020
Why it was recalled
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 4600 Vials
- Distribution pattern
- Ohio, Louisiana, Mississippi
Timeline
- Recall initiated
- 2020-02-07
- FDA classified
- 2020-02-20
- Posted by FDA
- 2020-02-26
- Terminated
- 2023-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0853-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.