SCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (leaking sterile injectable bags) are rated as Severe (4).
Plain-English summary
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Single Dose Container bag. The product is identified by NDC 70004-0737-32, Lot # 20170509@29, and a Use By date of 08/07/17.
The recall was initiated because the product bags were found leaking at the seam, which creates a lack of assurance of sterility. The affected product was distributed nationwide in the USA.
Healthcare providers and patients should check their inventory for this specific lot and stop using the product if it matches the description. The FDA has classified this as a Class II recall.
The recalled product
- Product
- MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Solution
- Affected units
- 40
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 # 20170509@29
- Use By: 08/07/17
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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