Reported Apr 22, 2015 · Terminated
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle,…
Apotex Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Inc. · 150 Signet Drive · Toronto, N/A · N/A
Is this the product you have?
- Bromfenac Ophthalmic Solution 0.09%, Rx Only
- Mfg ForApotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle
- NDC
60505-0595-5b) 2 x 1.7 mL Bottles
- NDC
60505-0595-6c) 2.5 mL Bottles
- NDC60505-0596-4
- Lot codes and dates
- a) Lot #: KY8498
- Expiry
01/2016b) Lot #: KY8496
- Expiry
01/2016c) Lot #: MC5426
- Expiry
02/2016Lot #: KZ2002
- Expiry04/2016
- Amount recalled
- 33,795 Bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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