SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl syringes because they may leak and lack assurance of 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, which corresponds to a Severe severity score according to the rubric.
Plain-English summary
SCA Pharmaceuticals is recalling fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringes (NDC# 70004-0229-05). The recall is due to a lack of assurance of sterility and the potential for the product to leak.
The affected lot is 20170512@19 with a beyond-use date of 8/10/2017. The product was distributed nationwide. This is a prescription-only medication.
Consumers and healthcare providers should stop using the recalled product and contact SCA Pharmaceuticals or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
- 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)
- Lot: 20170512@19 BUD: 8/10/2017
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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