June 2019 FDA Recall Lotemax by Bausch & Lomb
D-1396-2019 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Bausch & Lomb on June 17, 2019 for the product Lotemax. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1396-2019
Failed Stability Specifications: Out of specification for viscosity.
06-17-2019
06-19-2019
170832 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bausch & Lomb
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Batch or Lot Expiration Information
Lot# s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
