Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns
Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center is recalling 162 bags of Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container. The product is identified by NDC 69374-988-10 and includes lots AA9023A and AA9023B, both with an expiration date of 10/24/2019.
The recall was initiated due to a lack of assurance of sterility and the potential for the bags to leak. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the recalled product and contact Nephron Pharmaceuticals for further instructions.
The recalled product
- Product
- Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
- Category
- Drug — Injectable
- Hazard
- Affected units
- 162
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: AA9023A Exp. 10/24/2019
- AA9023B Exp. 10/24/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center 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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