Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution because the company cannot assure the product's sterility.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while no specific injuries are reported here, the 'lack of assurance of sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe tier for high-risk drug recalls.
Plain-English summary
Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe. The product is identified by NDC 42852-011-22 and Lot 10/18/18 2217 01122S, with an expiration date of 3/17/2019.
The recall was initiated due to a lack of assurance of sterility. The agency has classified this as a Class II recall, indicating a situation that might cause temporary or medically reversible health adverse effects, or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled syringes and contact Advanced Pharma Inc. at (877) 794-0404 or their facility at 9265 Kirby Dr., Houston, TX 77054 for further instructions.
The recalled product
- Product
- 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Solution
- Affected units
- 1,540
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 (1)
- Lot: 10/18/18 2217 01122S Exp. 3/17/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Advanced Pharma Inc. 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.
See all 19 products in this recall →Related recalls
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