FDA Drug recall D-0250-2021
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc
- FDA Drug
- Class III
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class III recall of Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc by Accord Healthcare, citing labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0250-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-01-28 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
Product
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
Reason
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Identifiers
| ndc | 16729-471-08 |
|---|---|
| ndc | 16729-472-08 |
| ndc | 16729-473-03 |
| ndc | 16729-474-03 |
| ndc | 16729-474-05 |
| ndc | 16729-472-30 |
| code_info | Lot: M2013645 Exp. Aug. 2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0250-2021%22
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