Glycopyrrolate Syringes Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 3450 glycopyrrolate injection syringes (NDC 69374-903-30, Lot GL2004A) nationwide due to lack of assurance of sterility.
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 for lack of sterility assurance in an injectable medication. No reported illnesses or injuries are mentioned in the source text, making this a theoretical risk-of-harm situation.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling 3450 pre-filled glycopyrrolate injection syringes due to lack of assurance of sterility. The affected product is Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), NDC 69374-903-30, Lot GL2004A, expiration date August 26, 2022. The product was distributed nationwide.
When injectable medications cannot be assured to be sterile, there is a risk of bacterial contamination. If a non-sterile injection is administered to a patient, it could introduce pathogenic organisms into the body, potentially causing serious infections.
If you have received this product, contact your healthcare provider or pharmacy for guidance. Do not use the recalled syringes.
The recalled product
- Product
- Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Parenteral
- Hazard
- bacterial-contamination
- infection
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: GL2004A
- Exp. 8/26/2022
Distribution
Distributed nationwide across the United States.
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