The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0202-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection syringes due to a lack of assurance of sterility and potential defective 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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury or structural defects (like a non-integral unit compromising sterility) are classified as Severe (Score 4).

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 50 syringes of morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe. The recall affects Lot # 1220023221 with a best-use date of 1/31/2021 and Lot # 1220023584 with a best-use date of 2/9/2021. The product is identified by barcode 70004010316.

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. The product was distributed to hospitals nationwide.

Healthcare facilities should check their inventory for the affected lot numbers and discontinue use of these syringes. Patients who have received this medication should contact their healthcare provider if they have concerns.

The recalled product

Product
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injection
Hazard
Affected units
50

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 (3)

  • Lot # 1220023221
  • BUD 1/31/2021 & 1220023584
  • BUD 2/9/2021.

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 →

Related recalls

Same manufacturer · SCA Pharmaceuticals

See all →

Same hazard · sterility

See all →

Similar recalls