Agency classClass IIOur severity:High FDA (Drugs)·D-0404-2024·Announced 2024-04-03

FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns

SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.

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 drug product. While no illnesses or injuries have been reported, a sterility failure poses a significant risk of infection from contamination if the product is administered to patients, making it a risk-of-harm product where injury has not yet been reported.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 20 mg/100 mL injections in Grey CADD Cassettes (NDC 70004-0300-63) because the manufacturer cannot assure that the product meets sterility standards. The recall affects 256 cassettes distributed nationwide.

The specific lot affected is #1223049529 with an expiration date of 01/03/24. A lack of assurance of sterility in injectable products means there is a potential risk that the product could be contaminated with bacteria or other microorganisms that could cause infections if administered to patients.

Healthcare facilities and pharmacies that received this product should cease use and contact SCA Pharmaceuticals or the FDA regarding proper handling and return of any remaining stock.

The recalled product

Product: HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable / Controlled Substance
Hazard: contamination
infection-risk
Affected units: 256

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 (2)

Lot #: 1223049529
Exp 01/03/24

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