Pharmacy Creations Recalls Lidocaine Injection Due to Sterility Concerns
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection vials because the company cannot guarantee the product is sterile.
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, which corresponds to a 'Severe' rating under the rubric for significant injury risks or hospitalization reports, even though specific injury counts are not provided in the text.
Plain-English summary
Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vials, containing EDTA disodium 150 mg/mL. The recall is being conducted due to a lack of assurance of sterility for the product.
The affected product is identified by Lot # 214490.00 with an expiration date of 11/29/2013. The recall involves 50 vials that were distributed in New Jersey.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
- Manufacturer
- Pharmacy Creations
- Category
- Drug — Sterile Injection
- Hazard
- Affected units
- 50
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)
- Lot # 214490.00
- Exp 11/29/2013
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Pharmacy Creations 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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