The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0250-2021·Announced 2021-02-17

Accord Recalls Glycopyrrolate Injection Due to Labeling Mix-up

Accord Healthcare is recalling 502 cartons of Glycopyrrolate Injection due to a packaging error where 2 mL vials were placed in 1 mL blister strips.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling mix-up without reported injuries.

Plain-English summary

Accord Healthcare, Inc. is voluntarily recalling 502 cartons of Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials. The recall is limited to Lot M2013645 with an expiration date of August 2022. The product was distributed nationwide.

The recall was initiated due to a labeling mix-up. Specifically, correctly labeled 2 mL vials were packaged into blister strips that were labeled for 1 mL vials. This packaging error could lead to confusion regarding the volume of the medication contained in the packaging.

The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare providers and patients should verify the lot number and expiration date of their Glycopyrrolate Injection against the recalled details. If the product matches the recalled lot, it should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand
GLYCOPYRROLATE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injection
Hazard
Affected units
502

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 (1)

  • Lot: M2013645 Exp. Aug. 2022

UPCs (4)

  • 0316729474054
  • 0316729472302
  • 0316729473316
  • 0316729471633

Distribution

Distributed nationwide across the United States.

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