Fagron Recalls LETS GEL Kits Due to Microbial Contamination

Plain-English summary

Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs (NDC: 51552-1539-1). The product is a prescription-only kit used to prepare 100 mL of LETS GEL, containing Lidocaine Hydrochloride, Ephinephrine Bitartrate, Tetracaine Hydrochloride, Sodium Metabisulfite, and SuturaGel Methlcellulose Base. The affected lots were distributed nationwide.

The recall was initiated due to microbial contamination of the non-sterile product. The source text does not specify the type of microorganism, the number of affected patients, or any reported illnesses or injuries.

Consumers and healthcare providers should stop using the affected kits and contact Fagron, Inc. or their healthcare provider for instructions on disposal or replacement. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product

LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription

Manufacturer

Fagron, Inc

Category

Drug — Topical Anesthetic

Hazard

• microbial-contamination

Affected units

11,912

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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