Lidocaine Hydrochloride Topical Solution recalled for being superpotent
Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 FDA classified this recall as Class I, which per the rubric mandates a minimum score of 4. The hazard involves a superpotent drug that could result in overdose or serious adverse effects in patients receiving topical treatment.
Plain-English summary
Teligent Pharma, Inc., located in Buena, NJ, has initiated a voluntary recall of Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles. The affected product has NDC 63739-997-64 and was manufactured by Teligent Pharma, Inc. and distributed by McKesson Corporation dba Sky Packaging.
The recall was initiated due to the product being superpotent. A total of 6,816 bottles have been affected. Lot #16345 with expiration date 01/2024 is involved in this recall.
The product was distributed to a wholesaler in Colorado, which further distributed it nationwide throughout the United States. The FDA classified this as a Class I recall on December 28, 2021, and the firm initiated the recall on November 30, 2021.
Patients who have received this medication should consult with their healthcare provider about their treatment. Healthcare providers and consumers in possession of affected product should contact their pharmacy or healthcare supplier for instructions on return or disposal.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Affected units
- 6,816
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 #: 16345
- Exp. Date 01/2024
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teligent 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.
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