Agency classClass IIOur severity:Severe FDA (Drugs)·D-0209-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 116 Morphine Sulfate 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious temporary or medically reversible health consequences.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 116 single-dose syringes of Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride. The recall was initiated because of 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 a prescription-only (Rx Only) medication classified as a Schedule II (CII) controlled substance. The specific lots involved are 1220023412 (Best Use Date 2/2/2021), 12220023500 (Best Use Date 2/3/2021), and 1220023689 (Best Use Date 2/11/2021). The product was distributed to hospitals nationwide.

Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Consumers should not use this product if they have it in their possession and should consult their healthcare provider for guidance.

The recalled product

Product: Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-cap
Affected units: 116

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 (4)

Lot # 1220023412
BUD 2/2/2021
12220023500
BUD 2/3/2021 & 1220023689 BUD 2/11/2021.

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