Agency classClass IIOur severity:High FDA (Drugs)·D-0396-2023·Announced 2023-03-08

Glycopyrrolate Injection, USP recalled for manufacturing practice deviations

Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations in a prescription injectable drug product. Manufacturing deviations represent risk-of-harm despite no reported illnesses, meeting the rubric criterion for high-severity recalls.

Plain-English summary

Accord Healthcare, Inc. is recalling Glycopyrrolate Injection, USP 0.2 mg/mL due to manufacturing practice deviations identified during FDA inspection. The affected product consists of single-dose vials distributed to the United States, including Puerto Rico, and Canada.

The recall affects six batches: R2200436, R2200159, R2200166, R2200618, R2201290, and R2201324, with expiration dates ranging from January 2024 to August 2024. Approximately 23,814 vials were distributed.

Healthcare providers with affected inventory should contact Accord Healthcare, Inc. for instruction on how to proceed. This is a Class II recall initiated by the recalling firm.

The recalled product

Product: GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand: GLYCOPYRROLATE
Manufacturer: Accord Healthcare, Inc.
Category: Drug — Prescription Injectable
Hazard: manufacturing-deviation
Affected units: 23,814

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Batches: R2200436
Exp. Date 1/31/2024
R2200159
R2200166
R2200618
Exp. Date 4/30/2024
R2201290
Exp. Date 8/31/2024
R2201324

UPCs (6)

0316729474054
0316729472302
0316729473316
0316729471633
316729471633
316729471084

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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Same hazard · manufacturing deviation