Agency classClass IIOur severity:High FDA (Drugs)·D-0405-2024·Announced 2024-04-03

HYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue

SCA Pharmaceuticals is recalling HYDROmorphone HCl injection syringes due to lack of assurance of sterility. The recall affects 5,734 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 an FDA Class II recall involving a sterility assurance issue with an injectable medication. No illnesses, injuries, or confirmed contamination are reported in the source documentation, which limits the score to High per the rubric's criterion for risk-of-harm products without reported injury.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection syringes due to a lack of assurance of sterility. The product is supplied in 35 mL plungerless syringes with a concentration of 0.2 mg/mL and carries NDC number 70004-0300-16.

The recall affects 5,734 syringes that were distributed nationwide in the United States. Multiple lot numbers are involved, with expiration dates ranging from November 2023 through January 2024.

HYDROmorphone is an opioid pain medication administered by injection and used in hospital and medical care settings.

The recalled product

Product: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable Analgesic
Hazard: contamination
sterility
Affected units: 5,734

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 (20)

Lot #: 1223048530
Exp 11/22/23
1223048692 Exp 11/29/23
1223048739 EXP 11/30/23
1223048826 Exp 12/05/23
1223048963 Exp 12/08/23
1223048964 EXP 12/11/23
1223049111 Exp 12/15/23
1223049128 Exp12/19/23
1223049210 EXP 12/21/23
1223049234 Exp 12/22/23
1223049257 Exp 12/22/23
1223049322 Exp 12/27/23
1223049416 Exp 12/28/23
1223049528 Exp 01/03/24
1223049559 Exp 01/04/24
1223049614 Exp 01/05/24
1223049632 Exp 01/08/24
1223049725 Exp 01/11/24
1223049792 Exp 01/15/24

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 →

Same manufacturer · SCA Pharmaceuticals, LLC

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Same hazard · contamination