Why it was recalled
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #CGP190001-A, Exp. 07/31/2020
Where it was sold
Ohio, Louisiana, Mississippi
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0853-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 7, 2020
- FDA report date
- Feb 26, 2020
- Quantity
- 4600 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0853-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84927
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #CGP190001-A, Exp. 07/31/2020
- Postal code
- 08520-1401
- Report date
- Feb 26, 2020
- Product type
- Drugs
- Recall number
- D-0853-2020
- Classification
- Class III
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 4600 Vials
- Termination date
- Mar 8, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Ohio, Louisiana, Mississippi
- Recall initiation date
- Feb 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2020