Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.
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 3/5 (High).
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 for a sterility defect in an injectable product. Although no illnesses or injuries have been reported, lack of sterility assurance in injected medications represents a significant risk of serious infection.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling labetalol HCl 20 mg/4mL Injection (5 mg/mL, 4 mL syringe) due to lack of assurance of sterility. The affected product includes 2,458 syringes with NDC 70004-0700-28 distributed nationwide.
Two lot numbers are affected: Lot #1223047334 (Exp 12/23/23) and Lot #1223048170 (Exp 02/01/24).
Labetalol is an injectable medication used to treat high blood pressure. Lack of sterility assurance in injectable products poses a risk of infection if the product has been compromised during manufacturing or storage.
Patients and healthcare providers should verify medication lot numbers and contact SCA Pharmaceuticals or their healthcare provider if they have received product from the affected lots. Affected medication should not be used.
The recalled product
- Product
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Affected units
- 2,458
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 (2)
- Lot #: 1223047334 Exp 12/23/23
- 1223048170 Exp 02/01/24
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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