SCA Pharmaceuticals Recalls Labetalol HCl Injection Due to Labeling Errors
SCA Pharmaceuticals is recalling 480 syringes of labetalol HCl injection because some labels display incorrect compounding and use-by dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 by definition is unlikely to cause adverse health consequences, and the issue is limited to incorrect date labeling.
Plain-English summary
SCA Pharmaceuticals, LLC. is recalling 480 syringes of labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, for IV Use. The product is identified by NDC 70004-0700-28 and UPC 70004070028. The specific lot affected is 1217000213, with an expiration date of 03/27/2019.
The recall was initiated due to labeling errors where some product labels incorrectly indicate a compounding date of 12/27/2018 and a use-by date of 03/27/2019. The correct dates for this lot are a compounding date of 12/27/2017 and a use-by date of 03/27/2018. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed in Georgia, Nebraska, and Pennsylvania. Healthcare providers and patients should check their inventory for this specific lot number and date discrepancies. If the product is found, it should be returned to SCA Pharmaceuticals, LLC. or the distributor.
The recalled product
- Product
- labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
- Manufacturer
- SCA Pharmaceuticals, LLC.
- Category
- Drug — Injection
- Hazard
- Affected units
- 480
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 1217000213
- exp 03/27/2019
Distribution
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