Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
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 a high-risk injectable pharmaceutical product with a serious potential hazard (lack of sterility assurance). However, the source text reports no illnesses, injuries, or hospitalizations. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) pre-filled syringes due to lack of assurance of sterility. The recall covers lots AS2001A (expiration 8/2/2022), AS2002A (expiration 8/17/2022), and AS2003A (expiration 9/3/2022).
Approximately 13,340 syringes were distributed nationwide in cartons of 5 pre-filled syringes, with 6 cartons per case. The product is manufactured by Nephron Sterile Compounding Center LLC, a FDA-registered 503B outsourcing facility in West Columbia, South Carolina. This is an FDA Class II recall.
Healthcare providers and facilities should immediately discontinue use of the affected lots and remove them from patient care areas. Patients and healthcare providers with questions about potential exposure to these lots should consult with their healthcare provider.
The recalled product
- Product
- Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, 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 Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Affected units
- 13,340
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 (6)
- Lots: AS2001A
- Exp. 8/2/2022
- AS2002A
- Exp. 8/17/2022
- AS2003A
- Exp. 9/3/2022.
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.
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