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FDAJanuary 28, 2021drug

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)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

accord healthcareaccord

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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