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
Reported: January 16, 2019 Initiated: December 20, 2018 #D-0387-2019
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
Reason for Recall
GMP Deviations: A silicone particulate was noted in Ozurdex.
Details
- Recalling Firm
- Allergan, PLC.
- Units Affected
- 133,716 Cartons
- Distribution
- Product was distributed to various accounts throughout the United States including VA and Government Accounts
- Location
- Madison, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Allergan, PLC.. Units affected: 133,716 Cartons.
Why was this product recalled? ▼
GMP Deviations: A silicone particulate was noted in Ozurdex.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0387-2019.
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