Lidocaine Hydrochloride Topical Solution recalled for CGMP deviations
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving manufacturing deviations and a defective seal that could affect product quality. No illnesses or injuries are reported in the source text, and the hazard is preventive in nature based on what was observed in related products at the same facility.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) in 50 mL glass bottles (NDC 52565-009-50) distributed nationwide. The recall affects Lot #13058 with expiration date 02/2022 and Lot #13768 with expiration date 05/2022, totaling 14,664 glass bottles.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were manufactured at the same facility and using the same components as products that had cracked seals in caps, which were found to contain superpotent material.
Patients currently taking this product should consult their healthcare provider or pharmacist regarding continuation of therapy. Consumers should not use recalled lots and should return them to the dispensing pharmacy.
The recalled product
- Product
- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Affected units
- 14,664
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 (3)
- Lot #: 13058
- Exp. date 02/2022 and 13768
- Exp. date 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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