Pharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 3,159 syringes of lidocaine HCl 2% because stability data does not support the expiry date, posing a risk of reduced potency.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a 'Severe' rating under the rubric, as it involves a potential loss of potency that may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Pharmedium Services, LLC is recalling 3,159 syringes of lidocaine HCl 2% (20 mg per mL), 3 mL total volume, prescription only. The recall is being conducted because stability data does not support the expiry date for the product, which may result in a potential loss of potency in the drug.
The affected product is identified by Product code 2R3450 and includes specific lot numbers with expiration dates ranging from July 15, 2015, to October 12, 2015. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide. Healthcare providers and patients should stop using the affected syringes and contact their pharmacist or the recalling firm for further instructions on return or replacement.
The recalled product
- Product
- lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 3,159
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 (13)
- Lot Numbers: 15117053M
- 15117054M
- 15124056M
- 15128001M
- 15128002M
- 15131021M
- 15133067M
- 15141028M
- 15147089M
- 15147090M
- 151740185M
- 151740188M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 recalled by Pharmedium Services, LLC 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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