January 2021 FDA Recall Glycopyrrolate by Accord Healthcare, Inc.
D-0250-2021 - Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
This Class III drug recall was voluntarily initiated by Accord Healthcare, Inc. on January 28, 2021 for the product Glycopyrrolate. The FDA reported the reason for recall as labeling; label mix-up; correctly labeled 2 ml vials were packaged into blister strips labeled for 1 ml vials. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0250-2021
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
01-28-2021
02-17-2021
502 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-08-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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)
Batch or Lot Expiration Information
Lot# Lot: M2013645 Exp. Aug. 2022
