SCA Pharmaceuticals Recalls Droperidol Injection Due to Particulate Presence
SCA Pharmaceuticals is recalling 421 syringes of Droperidol injection because of the presence of particulate matter. The product was distributed in Indiana, Arkansas, Missouri, and Minnesota.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 is assigned a severity score of 4 (Severe), particularly when involving injectable medications where particulate matter poses a risk of adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is recalling 421 syringes of Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe. The product is packaged in 10-count syringes per heat sealed bag and is compounded for office use. The recall is due to the presence of particulate matter in the injection.
The affected product is identified by Lot 20141223@20 and Bar Code 88888-7720-16. It was distributed in Indiana, Arkansas, Missouri, and Minnesota. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected syringes and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions or a return.
The recalled product
- Product
- Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 421
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: 20141223@20
Distribution
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