Agency classClass IIOur severity:Severe FDA (Drugs)·D-0871-2017·Announced 2017-06-07

SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking

SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, 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 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. According to the rubric, an FDA Class II recall involving a significant injury risk or structural defect (leaking injectable bags compromising sterility) corresponds to a score of 4 (Severe).

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag. The product is preservative-free, contains sulfites, and is available by prescription only. The specific NDC number is 70004-0100-55.

The recall is being issued due to a lack of assurance of sterility, as the product bags were found to be leaking at the seam. This defect poses a risk of contamination to the injectable solution.

The affected lots are 20170508@48 (Use By: 08/06/17) and 20170505@19 (Use By: 08/03/17). The product was distributed nationwide in the USA. Healthcare providers and patients should discontinue use of these specific lots and contact SCA Pharmaceuticals or their healthcare provider for further instructions.

The recalled product

Product: morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable
Hazard: sterility
leaking
Affected units: 56

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 # 20170508@48
Use By: 08/06/17
20170505@19
Use By: 08/03/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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