The Recall Desk
HighFDA (Drugs)·D-0387-2019·Announced 2019-01-16

Allergan Recalls Ozurdex Dexamethasone Implants Due to Silicone Particulate

Allergan is recalling 133,716 cartons of Ozurdex (dexamethasone) intravitreal implants because a silicone particulate was detected. The product was distributed to various accounts throughout the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II due to a GMP deviation (silicone particulate). Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

Allergan, PLC. is recalling 133,716 cartons of OZURDEX (dexamethasone intravitreal implant) 0.7 mg. The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically the detection of a silicone particulate in the product. The affected product is a single-use plastic applicator contained within a carton, available by prescription only.

The recalled product was distributed to various accounts throughout the United States, including VA and Government Accounts. The recall covers multiple lot numbers with expiration dates ranging from June 2019 to April 2021. The specific lots affected are: E78689, E78726, E78729, E78894, E79157, E79233, E79366, E79891, E80122, E80216, E81080, E81083, E81273, E81344, E82526, E82638, E82738, E82741, E82847, E82852, E83029, and E83364.

Healthcare providers and patients should stop using the affected lots of OZURDEX and contact Allergan or their local FDA office for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
OZURDEX (DEXAMETHASONE)
Brand
OZURDEX
Manufacturer
Allergan, PLC.
Category
Drug — Ophthalmic
Hazard
Affected units
133,716

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 (20)

  • 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

Distribution

Distributed in 1 state:

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