Agency classClass IIOur severity:Severe FDA (Drugs)·D-0195-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

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. The hazard involves a lack of assurance of sterility and a potential for a non-integral unit, which presents a significant risk of serious adverse health consequences, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 3,092 syringes of HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL). The recall involves two specific product configurations: 30 mL Plungerless Single Dose Syringes and 30 mL Single Dose Syringes. The affected lots have expiration dates ranging from January 25, 2021, to February 14, 2021.

The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. This defect poses a risk of contamination to the medication.

The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for the specific lot numbers and barcodes listed in the recall notice and stop using any affected units. Patients who have received this medication should consult their healthcare provider if they have concerns.

The recalled product

Product: HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-cap
contamination
Affected units: 3,092

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 (15)

a) Lot # 1220023171
BUD 1/26/2021
1220023282
BUD 2/1/2021
1220023446
BUD 2/7/2021
1220023532
BUD 2/8/2021
1220023650
BUD 2/11/2021 & 1220023727
BUD 2/14/2021. b) Lot # 1220023241
BUD 1/25/2021
1220023313
BUD 2/1/2021 & 1220023442
BUD 2/7/2021.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by SCA Pharmaceuticals 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 →

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Same hazard · sterility