The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0421-2024·Announced 2024-04-03

Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

SCA Pharmaceuticals is recalling Phenylephrine HCl 800 mcg/10 mL injections due to lack of assurance that the product is sterile. The recall affects 2,427 syringes distributed nationwide.

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 a Class II FDA recall for a sterility assurance failure in an injectable medication—a risk-of-harm product. Although no illnesses or injuries have been reported, the potential for serious infection from non-sterile injection meets the High severity threshold.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling Phenylephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, a medication used to treat low blood pressure. The recall involves 2,427 syringes with specific lot numbers (1223048610 exp. 04/10/24, 1223048611 exp. 04/10/24, 1223048726 exp. 04/13/24, 1223050163 exp. 06/12/24) that were distributed nationwide.

The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements. Injectable medications must be completely sterile to prevent serious infections at the injection site or in the bloodstream.

Healthcare facilities, pharmacies, and other distributors who received this medication should immediately quarantine affected lots and report any use to the FDA. This is a Class II recall issued by the U.S. Food and Drug Administration.

Patients and healthcare providers should not use the recalled syringes. Contact SCA Pharmaceuticals or the FDA with questions about this recall or if you have received or used any of the affected products.

The recalled product

Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID…
Manufacturer
SCA Pharmaceuticals, LLC
Category
Drug
Hazard
Affected units
2,427

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 (4)

  • Lot #: 1223048610 Exp 04/10/24
  • 1223048611 Exp 04/10/24
  • 1223048726 Exp 04/13/24
  • 1223050163 Exp 06/12/24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by SCA Pharmaceuticals, 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 32 products in this recall →

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