The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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

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