Why it was recalled
GMP Deviations: A silicone particulate was noted in Ozurdex.
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to various accounts throughout the United States including VA and Government Accounts
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-0387-2019
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Dec 20, 2018
- FDA report date
- Jan 16, 2019
- Quantity
- 133,716 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Allergan, PLC.
Original FDA data
Every field from FDA enforcement report D-0387-2019, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 81855
- Address
- 5 Giralda Farms
- Code information
- 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
- Postal code
- 07940-1027
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0387-2019
- Classification
- Class II
- Recalling firm
- Allergan, PLC.
- Product quantity
- 133,716 Cartons
- Reason for recall
- GMP Deviations: A silicone particulate was noted in Ozurdex.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to various accounts throughout the United States including VA and Government Accounts
- Recall initiation date
- Dec 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2019