December 2022 FDA Recall Glycopyrrolate by Aurolife Pharma, Llc
D-0087-2023 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Aurolife Pharma, Llc on December 16, 2022 for the product Glycopyrrolate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0087-2023
Failed Impurities/Degradation Specifications
12-16-2022
12-28-2022
7344 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurolife Pharma, LLC
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Batch or Lot Expiration Information
Lot# Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023
