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.
What this means for you
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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