SCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of 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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard of sterility failure in an IV medication is significant.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 450 bags of oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag. The product is prescription-only and was distributed nationwide in the United States. The specific lot number is 20170912@13, with a beyond-use date of 10/22/2017.
The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microorganisms, which poses a risk to patients who receive the medication.
Healthcare providers and patients should stop using the affected product immediately. Consumers should check their medication for the specific lot number and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — IV Medication
- Affected units
- 450
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 (1)
- Lot: 20170912@13 BUD: 10/22/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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