Glycopyrrolate Injection — Class III drug recall D-0853-2020
Terminated recall by AuroMedics Pharma LLC, reported 2020-02-26, distributed in LA, MS, OH. Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigat
| Recall number | D-0853-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2020-02-07 |
| Classified | 2020-02-20 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2023-03-08 |
| Distributed | LA, MS, OH |
| Quantity | 4,600 vials |
| Reason classes | specification failure |
| NDC | 55150-0292, 55150-0292-01, 55150-0293, 55150-0293-02, 55150-0294, 55150-0294-05, 55150-0295, 55150-0295-20 |
| Lot numbers | CGP190001-A |
| Expiration dates | 2020-07-31 |
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.
Reason for recall
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0853-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.