FDA's enforcement report lists an ongoing Class II recall, dated 23 September, of Lidocaine Ointment USP 5% in 50 g jars, manufactured by Taro and distributed by Sun Pharma/Taro. The reason given is failed content uniformity, with an out-of-specification assay result at the 24-month stability test.
A Class II recall means use of the product may cause temporary or medically reversible adverse effects, or that serious harm is remote. Content uniformity failure means some of the ointment may contain more or less lidocaine than labelled, which can affect both effectiveness and, with large applied areas, systemic exposure.
The recall concerns US-distributed product. Whether the same lots reached India is not stated, and CDSCO's position is unknown.
- Check whether your stock includes the recalled Taro 5% lidocaine ointment 50 g jars.
- Use an alternative supply for procedures relying on topical lidocaine if affected stock is found.
- Limit applied area and dose of topical lidocaine as usual to avoid systemic toxicity.
- Report any unexpected effect from topical lidocaine to pharmacovigilance.
Why it matters
Variable drug content in a topical anaesthetic affects both block quality and toxicity risk.
Don't overread it
A Class II recall for a manufacturing specification is not evidence of patient harm.
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