Skip to content
Recall Observatory FDA recall evidence

Drug product

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

D-0646-2016

January 18, 2016

Class III

Product summary

Firm
Bausch & Lomb, Inc.
Event
Event 73032
Status
Terminated
Classification
Class III
Quantity
119,393 Bottles
Official record key
drug-enforcement:D-0646-2016

Official wording

Reason: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Code information: Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017.

Distribution pattern: U.S. Nationwide including Puerto Rico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing