Agency classClass IIOur severity:High FDA (Drugs)·D-1253-2022·Announced 2022-07-27

Glycopyrrolate Injection Recalled for Lack of Sterility Assurance

Nephron is recalling Glycopyrrolate Injection pre-filled syringes distributed nationwide due to lack of sterility assurance. The recall affects 3,690 syringes from lot GL2001A, expiration 7/15/2022.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: This is an FDA Class II recall of an injectable medication with a lack of sterility assurance. No illnesses or injuries have been reported. Injectable products lacking sterility assurance pose a risk of microbial contamination; the absence of reported cases classifies this as a High-severity risk-of-harm product rather than Severe.

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) pre-filled syringes. The recall involves 3,690 syringes from lot GL2001A with an expiration date of 7/15/2022.

The reason for the recall is lack of assurance of sterility. Sterility is essential for injectable medications to ensure product safety.

The recalled product was distributed nationwide in the United States. Healthcare facilities, pharmacies, and distributors should immediately stop dispensing syringes from lot GL2001A and contact Nephron Sterile Compounding Center LLC or their supplier.

Patients who may have received Glycopyrrolate Injection from the affected lot should consult with their healthcare provider. Healthcare providers are advised to review patient records and monitor for any potential complications.

The recalled product

Product: Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 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: 69374-903-05
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable Drug
Hazard: lack-of-sterility
microbial-contamination
Affected units: 3,690

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)

Lots: GL2001A
Exp. 7/15/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 37 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.

See all 37 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

See all →

High
Sodium Chloride Injection Recalled for Potential Sterility Compromise
FDA (Drugs) · 2025-03-19
High
Norepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
High
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
FDA (Drugs) · 2023-03-08
High
Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
High
FDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08

Same hazard · lack of sterility