Agency classClass IIOur severity:High FDA (Drugs)·D-0410-2024·Announced 2024-04-03

Hydromorphone Injection Recalled for Lack of Sterility Assurance

SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.

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: FDA Class II recall with no reported illnesses or hospitalizations. Non-sterile injections present a serious risk of infection, but injury has not yet been reported.

Plain-English summary

SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL (1 mg/mL concentration) in 0.9% Sodium Chloride Injection across the United States. The affected product is a prescription injectable opioid medication.

The recall is due to lack of assurance of sterility in the recalled syringes. Non-sterile injections could result in serious infection or other complications when administered.

The affected lots include Lot# 1223048258 (expiration 11/10/23), Lot# 1223048890 (expiration 12/07/23), and Lot# 1223049134 (expiration 12/19/23). The product is manufactured by SCA Pharmaceuticals, LLC (Windsor, CT) and identified by NDC 70004-0303-21.

Healthcare providers and patients currently using affected lots should discontinue use immediately and consult with their healthcare provider.

The recalled product

Product: HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable Opioid
Hazard: lack-of-sterility
infection-risk
Affected units: 909

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 (3)

Lot#: 1223048258 Exp 11/10/23
1223048890 Exp 12/07/23
1223049134 Exp 12/19/23

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 →

Same manufacturer · SCA Pharmaceuticals, LLC

See all →

High
Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
High
Injectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
High
Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
High
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
High
HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03

Same hazard · lack of sterility