The Recall Desk
HighFDA (Drugs)·D-0409-2024·Announced 2024-04-03

FDA recalls HYDROmorphone injection for lack of sterility assurance

SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.

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: FDA Class II recall of injectable drug product lacking sterility assurance. While non-sterile injectable products pose significant infection risk, no illnesses or injuries have been reported, meeting the High-severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection supplied in 30 mL plungerless syringes (NDC 70004-0303-16). The recall is due to lack of assurance of sterility—the manufacturer cannot confirm that units meet required sterility standards.

The recall affects 5,392 syringes distributed nationwide. Eighteen lot numbers are affected with expiration dates ranging from November 15, 2023 through January 25, 2024: lots 1223048357, 1223048461, 1223048486, 1223048694, 1223048865, 1223048967, 1223049098, 1223049133, 1223049175, 1223049268, 1223049457, 1223049561, 1223049604, 1223049648, 1223049870, 1223049942, 1223049973, and 1223050060.

Healthcare providers and patients who may have received these products should consult with the FDA or SCA Pharmaceuticals for guidance on appropriate steps. No illnesses or adverse events have been reported in connection with this recall.

The recalled product

Product
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
Manufacturer
SCA Pharmaceuticals, LLC
Category
Drug — Injectable - Opioid
Hazard
  • lack-of-sterility
  • contamination-risk
  • infection-risk

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 (18)

  • Lot #: 1223048357 Exp 11/15/23
  • 1223048461 EXP 11/20/23
  • 1223048486 EXP 11/21/23
  • 1223048694 EXP 12/01/23
  • 1223048865 EXP 12/06/23
  • 1223048967 EXP 12/11/23
  • 1223049098 EXP 12/15/23
  • 1223049133 EXP 12/19/23
  • 1223049175 EXP 12/20/23
  • 1223049268 EXP 12/25/23
  • 1223049457 EXP 01/01/24
  • 1223049561 EXP 01/04/24
  • 1223049604 EXP 01/05/24
  • 1223049648 EXP 01/09/24
  • 1223049870 EXP 01/17/24
  • 1223049942 EXP 01/19/24
  • 1223049973 EXP 01/23/24
  • 1223050060 EXP 01/25/24

Distribution

Distributed nationwide across the United States.

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