Agency classClass IIOur severity:Severe FDA (Drugs)·D-0060-2018·Announced 2017-11-08

SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 128 syringes of Hydromorphone HCL 1 mg/mL due to a lack of assurance of sterility. The product was 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

SCA Pharmaceuticals, LLC is recalling 128 single-dose syringes of HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride. The specific product is the 25 mL fill in 30 mL syringe with NDC 70004-0303-17. The recall is being conducted because of a lack of assurance of sterility.

The affected lot number is 20170808@52, with a beyond-use date of 11/06/2017. The product was distributed nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
Manufacturer: SCA Pharmaceuticals, LLC
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 128

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 (1)

Lot: 20170808@52 BUD: 11/06/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Same manufacturer · SCA Pharmaceuticals, LLC

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Same hazard · sterility