Agency classClass IIOur severity:High FDA (Drugs)·D-0999-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Morphine Sulfate Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling 220 bags of morphine sulfate in 0.9% sodium chloride because the product was made with recalled saline bags that may leak, compromising sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medication (morphine) with a potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

SCA Pharmaceuticals is recalling 220 bags of morphine sulfate 1 mg per mL in 0.9% Sodium Chloride. The product is a 100 mL single-dose container bag labeled as NDC 70004-0100-59 and NDC 70004-100-58. The recall is due to a lack of assurance of sterility, as the product was manufactured using recalled 0.9% sodium chloride bags that have the potential to leak.

The affected lots are 20170707@34 (BUD: 10/5/2017), 20170710@21 (BUD: 10/8/2017), and 20170706@44 (BUD: 10/4/2017). The product was distributed nationwide in the USA. The FDA has classified this recall as Class II.

Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions. The recall is voluntary and precautionary to ensure patient safety regarding sterility.

The recalled product

Product: morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
infection-risk
Affected units: 220

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 (6)

Lots: a) 20170707@34
BUD:10/5/2017
20170710@21
BUD: 10/8/2017
b) 20170706@44
BUD: 10/4/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · SCA Pharmaceuticals

See all →

High
SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
Moderate
FDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
Moderate
Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
Moderate
Norepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
Moderate
Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11

Same hazard · sterility