CMC Enterprise Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns
CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip due to a lack of sterility assurance. The 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. Per the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance) without reported fatalities or hospitalizations is classified as Severe.
Plain-English summary
CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only. The recall was initiated because of a lack of sterility assurance in the manufacturing process.
The affected products were distributed in North Carolina. The specific lots involved are ED041901 (Exp. 4/13/2019), ED051901 (Exp. 4/14/2019), ED081901 (Exp. 4/17/2019), ED01901 (Exp. 4/18/2019), ED101901 (Exp. 4/19/2019), and ED111901 (Exp. 4/20/2019).
Consumers and healthcare providers should stop using these products and contact CMC Enterprise Pharmacy for further instructions or a return.
The recalled product
- Product
- Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, 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
- 705
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: ED041901 Exp. 4/13/2019
- ED051901 Exp. 4/14/2019
- ED081901 Exp. 4/17/2019
- ED01901 Exp. 4/18/2019
- ED101901 Exp. 4/19/2019
- ED111901 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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