The Recall Desk
SevereFDA (Drugs)·D-0323-2022·Announced 2022-01-05

SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance

SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of an injectable drug involving a fundamental sterility defect. Injectable products without assured sterility pose serious risk of infection and hospitalization; the hazard is systemic and affects a large distributed population, meeting the criteria for Severe.

Plain-English summary

SterRx, LLC is recalling PHENYLephrine HCl, 40 mg per 250 mL (160 mcg per mL) in 0.9% Sodium Chloride Injection, NDC 70324-252-01, a prescription injectable medication. The recall was initiated due to lack of assurance of sterility.

Approximately 20,640 bags have been distributed nationwide throughout the United States. The affected product includes multiple lot codes issued between December 2021 and April 2022.

Patients and healthcare providers who have this product in stock should discontinue use and contact SterRx for return instructions. Healthcare facilities should verify that affected lots are not in active use and quarantine any remaining stock.

The recalled product

Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Parenteral
Hazard
  • lack-of-sterility
  • microbial-contamination
  • infection-risk

Distribution

Distributed nationwide across the United States.

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