PharMEDium Recalls Subpotent Buffered Lidocaine HCl Syringes Nationwide
PharMEDium Services is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl because the product was found to be subpotent.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is subpotency, which poses a risk of treatment failure.
Plain-English summary
PharMEDium Services, LLC. is voluntarily recalling 7,711 syringes of 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate). The affected products are available in two configurations: 1 mL in 3 mL BD Syringes and 5 mL in 5 mL BD Syringes, both sold in cartons of 10. The recall was initiated on January 2, 2019, and was classified as Class II by the FDA.
The reason for the recall is that the product was found to be subpotent, meaning it contained less of the active ingredient than labeled. The affected lots are identified by Service Codes 2K2466 and 2K2470, along with specific NDC codes listed in the recall documentation. The products were distributed throughout the United States.
Consumers and healthcare providers should check their inventory for the specific service codes and NDC numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer. The recall status is currently terminated.
The recalled product
- Product
- 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land…
- Manufacturer
- PharMEDium Services, LLC.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 7,711
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 (19)
- Service Code 2K2466 and 2K2470 183320004S
- 183330008S
- 183340002S
- 183340003S
- 183300004S
- 183310007S
- 183370041S
- 183310043S
- 183370042S
- 183320003S
- 183380007S
- 183250013S
- 183250014S
- 183320005S
- 183330009S
- 183370007S
- 183390044S
- 183400006S
- 183410003S.
Distribution
Distribution scope not specified by the agency.
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