Glycopyrrolate Injection Recalled Due to Lack of Sterility Assurance
Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.
What this means for you
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 of an injectable drug product with a sterility assurance deficiency. No illnesses or injuries have been reported, and the hazard is theoretical (lack of assurance rather than confirmed contamination), which limits the severity to High per the rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Glycopyrrolate Injection, USP, 0.2 mg/mL supplied in 3 mL pre-filled syringes. The recall affects 6,150 syringes from Lot GL2002A with an expiration date of August 13, 2022, distributed nationwide in the USA.
The recall was issued due to lack of assurance of sterility. This means the manufacturer cannot provide assurance that the injectable product meets required sterility standards.
Any recipient of the affected lot should stop using this product immediately and contact their supplier for instructions on returning or disposing of the recalled units.
The recalled product
- Product
- Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- Affected units
- 6,150
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 (2)
- Lot: GL2002A
- Exp. 8/13/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Nephron Sterile Compounding Center LLC 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.
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