The Recall Desk
HighFDA (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.

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: 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

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.

Related recalls

Same category