Class III
Terminated
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)
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- January 28, 2021
- Posted
- February 17, 2021
- Recall Number
- D-0250-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 502 cartons
- Firm Location
- Durham, NC, United States
Reason for Recall
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Distribution
Nationwide
Lot / Code Info
Lot: M2013645 Exp. Aug. 2022
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