Z-1554-2014Class II

Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile

Name: Z-1554-2014 Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile
Creator: Bausch & Lomb Inc- Greenville Solutions Plant
Published: 2014-04-21
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2014-04-21 / Terminated / root cause: manufacturing process

FDA source

Bausch & Lomb Inc- Greenville Solutions Plant began a recall of Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile on 2014-04-21. FDA classified it as Class II and gives the reason as "Out of specification results for one of the two disinfectants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1554-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-21
Posted: 2014-05-06
Terminated: 2015-01-09
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Product code: LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Reason for recall: Out of specification results for one of the two disinfectants.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified via registered mail starting 04/21/2014.
Quantity in commerce: 256,440 bottles
Distribution: US Nationwide.
Product codes and lots: Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1554-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1554-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code LYL

K083757Class IIBpz02 Multipurpose SolutionBausch & Lomb, Inc. / cleared 2009-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)