Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable medication. Although no illnesses or injuries have been reported, the hazard—compromised sterility assurance—presents a risk of serious infection in injectable products, meeting the criteria for a high-severity rating.
Plain-English summary
SCA Pharmaceuticals, LLC has recalled fentanyl injection syringes. The product is fentanyl 2,500 mcg/50 mL (50 mcg/mL) in 0.9% Sodium Chloride, provided in single-dose syringes. The recall affects 500 syringes distributed nationwide in the USA.
The recall was issued because the manufacturer could not assure that the product was sterile. Sterility is essential for injected medications, as non-sterile injections can result in infection.
Healthcare facilities and patients who received doses from these affected lots should be aware of the recall. The affected lot numbers are: Lot #1223048959 (Expires 12/11/23), Lot #1223049009 (Expires 12/12/23), Lot #1223049170 (Expires 12/20/23), and Lot #1223049245 (Expires 12/22/23).
Anyone who has received an injection from these lots should contact SCA Pharmaceuticals or their healthcare provider. As of now, no illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Opioid
- Affected units
- 500
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 #: 1223048959
- Exp 12/11/23
- 1223049009
- Exp 12/12/23
- 1223049170
- Exp 12/20/23
- 1223049245
- Exp 12/22/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals, LLC 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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