Recalls / Class II
Class IID-0387-2019
Product
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07
- Brand name
- Ozurdex
- Generic name
- Dexamethasone
- Active ingredient
- Dexamethasone
- Route
- Intravitreal
- NDC
- 0023-3348
- FDA application
- NDA022315
- Affected lot / code info
- E78689, exp. date 06/21/2019 E78726, exp. date 06/29/2019 E78729, exp. date 07/01/2019 E78894, exp. date 08/09/2019 E79157, exp. date 09/05/2019 E79233, exp. date 09/15/2019 E79366, exp. date 10/06/2019 E79891, exp. date 12/07/2019 E80122, exp. date 01/18/2020 E80216, exp. date 02/06/2020 E81080, exp. date 05/09/2020 E81083, exp. date 05/22/2020 E81273, exp. date 05/31/2020 E81344, exp. date 06/21/2020 E82526, exp. date 12/11/2020 E82638, exp. date 12/20/2020 E82738, exp. date 01/18/2021 E82741, exp. date 01/23/2021 E82847, exp. date 01/29/2021 E82852, exp. date 02/01/2021 E83029, exp. date 02/26/2021 E83364, exp. date 04/18/2021
Why it was recalled
GMP Deviations: A silicone particulate was noted in Ozurdex.
Recalling firm
- Firm
- Allergan, PLC.
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 Giralda Farms, Madison, New Jersey 07940-1027
Distribution
- Quantity
- 133,716 Cartons
- Distribution pattern
- Product was distributed to various accounts throughout the United States including VA and Government Accounts
Timeline
- Recall initiated
- 2018-12-20
- FDA classified
- 2019-01-18
- Posted by FDA
- 2019-01-16
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.