FDA Drug recall D-0853-2020
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…
- FDA Drug
- Class III
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class III recall of 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… by Auromedics Pharma, citing failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0853-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-02-07 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | LA, MS, OH |
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
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Identifiers
| ndc | 55150-292-01 |
|---|---|
| ndc | 55150-293-02 |
| ndc | 55150-294-05 |
| ndc | 55150-295-20 |
| code_info | Lot #CGP190001-A, Exp. 07/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0853-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.