CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1 for intradermal use due to a lack of sterility assurance.
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 the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an injectable drug) are rated as Severe.
Plain-English summary
CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL, intended for intradermal use only. The product was manufactured by Enterprise Pharmacy in Charlotte, North Carolina.
The recall was initiated due to a lack of sterility assurance. The affected lots are ED051902 (expiration date 4/14/2019) and ED101902 (expiration date 4/19/2019). The product was distributed in North Carolina.
Consumers and healthcare providers should stop using the affected product and contact CMC Enterprise Pharmacy for further instructions or a refund.
The recalled product
- Product
- Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 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
- Affected units
- 40
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)
- Lots: ED051902 Exp. 4/14/2019
- ED101902 Exp. 4/19/2019
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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