SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Infusion Bags
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
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, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential for serious adverse health consequences such as loss of sterility in an injectable product.
Plain-English summary
SCA Pharmaceuticals is recalling fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, NDC# 70004-0260-40. The recall is limited to Lot 20170509@17 with a best-use date of 8/7/2017. The product was distributed nationwide.
The recall was initiated because the product has a lack of assurance of sterility and has the potential to leak. This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should discontinue use of the affected product. Consumers should check their medication for the specific lot number and best-use date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
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)
- Lots: 20170509@17 BUD: 8/7/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 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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