Labetalol Syringes Recalled for Lack of Sterility Assurance
CMC Enterprise Pharmacy is recalling 6,667 Labetalol syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.
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. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the snippet, the agency's Class II classification for a sterility failure in a parenteral drug mandates a score of at least 4.
Plain-English summary
CMC Enterprise Pharmacy is recalling 6,667 syringes of Labetalol 20 mg/4 mL. The recall was initiated because the products lack sterility assurance. The affected lots include EA241908, EB011905, EB081909, EB151910, EB251909, EC061907, and EC151906, with expiration dates ranging from April 24, 2019, to June 13, 2019.
The recalled products were distributed in North Carolina. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected Labetalol syringes and contact CMC Enterprise Pharmacy for further instructions or a replacement.
The recalled product
- Product
- Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Manufacturer
- CMC Enterprise Pharmacy
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,667
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 (7)
- Lots: EA241908 Exp. 4/24/2019
- EB011905 Exp. 5/2/2019
- EB081909 Exp. 5/9/2019
- EB151910 Exp. 5/16/2019
- EB251909 Exp. 5/26/2019
- EC061907 Exp. 6/4/2019
- EC151906 Exp. 6/13/2019
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by CMC Enterprise Pharmacy 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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