Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
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 medication with a serious potential hazard—sterility failure—affecting a large volume of product nationwide. No illnesses or injuries are reported in the source, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling glycopyrrolate injection, USP 1 mg/5 mL (0.2 mg/mL), preservative-free, supplied in pre-filled syringes. The affected lot is GL2002B with an expiration date of August 13, 2022 (NDC 69374-903-05).
The recall is due to a lack of assurance of sterility. The manufacturer cannot guarantee that the product meets the sterility standards required for injectable medications.
Approximately 32,550 pre-filled syringes in various carton configurations have been distributed nationwide in the United States under this lot number.
The recalled product
- Product
- Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- sterility-failure
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: GL2002B Exp. 8/13/2022
Distribution
Distributed nationwide across the United States.
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