Why it was recalled
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Product description
Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
U.S. Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0646-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 18, 2016
- FDA report date
- Feb 3, 2016
- Quantity
- 119,393 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch & Lomb, Inc.
Original FDA data
Every field from FDA enforcement report D-0646-2016, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 73032
- Address
- 8500 Hidden River Pkwy
- 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.
- Postal code
- 33637-1014
- Report date
- Feb 3, 2016
- Product type
- Drugs
- Recall number
- D-0646-2016
- Classification
- Class III
- Recalling firm
- Bausch & Lomb, Inc.
- Product quantity
- 119,393 Bottles
- Termination date
- Jan 6, 2020
- Reason for recall
- Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Jan 18, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 28, 2016