LETS GEL KIT Convenience Pack recall: Sterility Concern
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate…
Why was LETS GEL KIT Convenience Pack recalled?
Microbial contamination of non-sterile product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot, expiry: 18F25-U03-044296, 11/8/2019; 18F25-U04-044297, 11/8/2019; 18H22-U06-045284, 1/24/2020; 18I24-U05-045853, 11/8/2019; 18K06-U03-047041, 1/24/2020; 18K06-U04-047042, 1/24/2020; 18K27-U11-047460, 3/16/2020; 18K28-U10-047519, 3/16/2020; 19A06-U02-048182, 3/16/2020; 19A06-U03-048183, 3/16/2020; 19A16-U13-048363, 3/16/2020; 19A21-U02-048503, 3/16/2020; 19B10-U02-048787, 3/16/2020; 19B14-U05-048781, 3/16/2020; 19C05-U01-049199, 3/16/2020; 19C05-U02-049200, 3/16/2020; 19C11-U07-049451, 3/16/2020 19C25-U02-048758, 3/16/2020; 19D07-U01-049884, 3/16/2020; 19D07-U02-049885, 3/16/2020; 19E09-U01-050298, 3/16/2020; 19E23-U01-050763, 9/11/2020; 19F16-U12-000052, 9/11/2020; 19F16-U13-000053, 10/24/2020; 19G07-U01-000357, 10/24/2020; 19G07-U02-000358, 10/24/2020; 19G21-U01-000930, 10/24/2020; 19G21-U02-000931, 12/17/2020; 19H01-U01-001172, 12/17/2020; 19H01-U02-001174, 12/17/2020; 19I03-U01-002019, 2/4/2021; 19I03-U02-002020, 2/4/2021; 19I03-U03-002021, 12/17/2020
- Product
- LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate…
- Recalling firm
- Fagron, Inc
- Quantity
- 11,912 kits
- Distribution
- Nationwide
- Recall date
- December 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)