Fagron Recalls LETS GEL Kits Due to Microbial Contamination
Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves microbial contamination of a pharmaceutical product, which is a high-risk hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
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
- 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.
Lot numbers (20)
- Lot
- expiry: 18F25-U03-044296
- 11/8/2019
- 18F25-U04-044297
- 18H22-U06-045284
- 1/24/2020
- 18I24-U05-045853
- 18K06-U03-047041
- 18K06-U04-047042
- 18K27-U11-047460
- 3/16/2020
- 18K28-U10-047519
- 19A06-U02-048182
- 19A06-U03-048183
- 19A16-U13-048363
- 19A21-U02-048503
- 19B10-U02-048787
- 19B14-U05-048781
- 19C05-U01-049199
- 19C05-U02-049200
Distribution
Distributed nationwide across the United States.
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