SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide 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 recall is classified as FDA Class II and involves a lack of assurance of sterility for an injectable medication, which poses a significant risk of infection or serious injury.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 6,710 units of fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe. The product is a Schedule II prescription-only medication manufactured by SCA Pharmaceuticals in Windsor, Connecticut.
The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. The affected lots include #1220023109, #1220023255, #1220023256, #1220023257, #1220023334, and #1220023518, with expiration dates ranging from January 25, 2021, to February 8, 2021.
The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected syringes. Patients who have received this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,710
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 (10)
- Lot #1220023109
- BUD 1/25/2021
- 1220023255
- BUD 1/26/2021
- 1220023256. BUD 1/26/2021
- 1220023257
- BUD 1/28/2021
- 1220023334
- BUD 2/2/2021 & 1220023518
- BUD 2/8/2021.
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.
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