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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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