SCA Pharmaceuticals Recalls Fentanyl Injection Due to Low Potency
SCA Pharmaceuticals is recalling specific lots of Fentanyl injection for IV or IM use because stability testing showed low potency.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 4,843 syringes of Fentanyl, 250 mcg/5mL, Injection for IV or IM use. The recall is due to an out-of-specification stability test result indicating low potency.
The affected product was distributed to three hospitals in Missouri and Louisiana. The specific lots involved are 1220021578 (Exp 12/2/2020), 1220021732 (Exp 12/9/2020), 1220022385 (Exp 12/29/2020), and 1220022582 (Exp 1/6/2021).
The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. Healthcare facilities should check their inventory for these specific lot numbers and stop using the product if found.
The recalled product
- Product
- Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 4,843
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 #: 1220021578
- Exp 12/2/2020
- 1220021732
- Exp 12/9/2020
- 1220022385
- Exp 12/29/2020
- 1220022582
- Exp 1/6/2021
Distribution
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