The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0201-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 751 syringes of Morphine Sulfate 3 mg/3 mL due to a lack of assurance of sterility and potential defective caps.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is typically a score of 1 or 2. It is scored as 2 (Moderate) because it involves a potential sterility issue with a prescription drug, which is a low-risk contamination or voluntary precautionary recall scenario without reported injuries.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 751 single-dose syringes of Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride. The recall is 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 affected product is identified by Lot # 1220023452 with a beyond-use date of 2/7/2021. The product was distributed to hospitals nationwide.

Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
Manufacturer
SCA Pharmaceuticals
Category
Drug — Prescription Injectable
Hazard
Affected units
751

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 # 1220023452
  • 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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