Drug recall D-0250-2021

Class III Terminated reported Feb 17, 2021

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 for recall

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Lots and codes

Lot: M2013645 Exp. Aug. 2022

Recall details

Recalling firm
Accord Healthcare, Inc., Durham, NC
Quantity
502 cartons
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 28, 2021
Terminated
February 8, 2022

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