Agency classClass IIOur severity:High FDA (Drugs)·D-0406-2024·Announced 2024-04-03

HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues

SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were 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 an FDA Class II recall of a sterile injectable drug where sterility assurance cannot be verified. Although no illnesses have been reported, lack of sterility in injectable products creates a serious potential risk of infection. The product qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

SCA Pharmaceuticals is recalling HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride injectable syringes (NDC 70004-0300-18) due to lack of assurance of sterility. The recall affects 1,425 syringes distributed nationwide in the USA.

The recalled product does not meet sterility assurance standards required for injectable medications. Injectable drugs must be sterile to prevent serious infections when administered to patients.

Affected lot numbers are: 1223048451 (Exp 11/20/23), 1223048923 (Exp 12/07/23), 1223049097 (Exp 12/15/23), and 1223049129 (Exp 12/19/23). Healthcare providers and pharmacies who have received these lots should stop dispensing them immediately. Patients who have received doses from recalled syringes should contact their healthcare provider.

The recalled product

Product: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable / Pain Management
Hazard: lack-of-sterility
Affected units: 1,425

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 #: 1223048451 Exp 11/20/23
1223048923 Exp 12/07/23
1223049097 Exp 12/15/23
1223049129 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

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Same hazard · lack of sterility