CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a product intended for intradermal use, which poses a significant risk of infection or injury.
Plain-English summary
CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringes intended for intradermal use only. The recall was initiated because of a lack of sterility assurance for the product.
The affected product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina. The recall covers 1,135 syringes distributed in North Carolina. Specific lot numbers and expiration dates are listed in the official recall notice.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the syringes.
The recalled product
- Product
- Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, 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
- 1,135
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 (6)
- Lots: ED041902 Exp. 4/13/2019
- ED051903 Exp. 04/14/2019
- ED081902 Exp. 4/17/2019
- ED091902 Exp. 4/18/2019
- ED101903 Exp. 4/19/2019
- ED111902 Exp. 4/20/2019
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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