SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes due to a lack of assurance of sterility and potential defective caps.
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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for serious injury or hospitalization (implied by sterility failure in a drug product) corresponds to a severity score of 4 (Severe).
Plain-English summary
SCA Pharmaceuticals is recalling 1,774 single-dose syringes of fentanyl 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride. The recall is being conducted because of a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.
The affected product was distributed to hospitals nationwide. The recall includes specific lots with expiration dates ranging from February 15, 2021, to March 1, 2021. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and returned to SCA Pharmaceuticals or disposed of according to local regulations.
The recalled product
- Product
- fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 1,774
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 (8)
- Lot # 1220023275
- BUD 2/15/2021
- 1220023312
- 1220023433
- 2/22/2021
- 1220023515
- BUD 2/24/2021 & 1220023671
- BUD 3/1/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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.
See all 32 products in this recall →Related recalls
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