Apotex Recalls Bromfenac Ophthalmic Solution Due to CGMP Deviations
Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09% because an excipient was not re-tested at the appropriate date.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09%, Rx Only. The product is available in 1.7 mL bottles (NDC: 60505-0595-5), 2 x 1.7 mL bottles (NDC: 60505-0595-6), and 2.5 mL bottles (NDC: 60505-0596-4). The affected lots are KY8498 (Expiry: 01/2016), KY8496 (Expiry: 01/2016), MC5426 (Expiry: 02/2016), and KZ2002 (Expiry: 04/2016).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a product excipient was not re-tested at the appropriate date. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The product was distributed nationwide in the United States. Consumers and healthcare providers should discontinue use of the affected lots and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
- Manufacturer
- Apotex Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 33,795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) Lot #: KY8498
- Expiry: 01/2016
- b) Lot #: KY8496
- c) Lot #: MC5426
- Expiry: 02/2016
- Lot #: KZ2002
- Expiry: 04/2016.
Distribution
Distributed nationwide across the United States.
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