SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
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 involving potential serious health consequences, such as sterility failures in injectable drugs, are categorized as Severe.
Plain-English summary
SCA Pharmaceuticals is recalling 2,834 syringes of fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only. The recall is due to a lack of assurance of sterility, which may result from a defective syringe cap that creates a non-integral unit.
The affected product was distributed to hospitals nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots with expiration dates ranging from January 20, 2021, to February 9, 2021.
Hospitals and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. Patients should consult their healthcare providers if they have questions regarding the medication they received.
The recalled product
- Product
- fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,834
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 (13)
- Lot # 1220022977
- BUD 1/20/2021
- 1220023122
- BUD 1/25/2021
- 1220023209
- BUD 1/28/2021
- 1220023248
- BUD 1/27/2021
- 1220023319
- BUD 2/1/2021
- 1220023496
- BUD 2/8/2021 & 1220023560
- BUD 2/9/2021.
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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