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Allergan Recall Triggered by User Complaints

Patrick Murray1 year ago

Allergan, a pharmaceutical company based out of New Jersey, has issued a voluntary recall of numerous eye ointments due to a number of consumer complaints.

List of Allergan Products Being Recalled

Allergan’s recall covers several specific products over a large number of lots. The products being recalled are:

  • REFRESH Lacri-Lube 3.5g (NDC 0023-0312-04)
  • REFRESH Lacri-Lube 7g (NDC 0023-0312-07)
  • REFRESH P.M. 3.5g (NDC 0023-0240-04)
  • REFRESH 3.5g (Professional Sample Pack) (NDC 0023-0240-04)
  • FML (fluorometholone ophthalmic ointment) 0.1%, 3.5g (NDC 0023-0316-04)
  • Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5g (NDC 0023-0313-04)

The specific lot numbers and expiration dates (ranging from April 2017 to March 2018) can be found in the FDA release, and can be found on the bottom flap of the carton with the safety seal and also on the crimp seal of the tube itself.

About the Recalled Ointments

According to a Medscape report, a number of customers have found a “small black particle attached to the product’s cap.” When the user attempts to unscrew the cap from the aluminum tube, the particle is at risk of detaching and making its way into the ointment.

Once it has made its way into the ointment, the consumer is at risk of accidentally applying the particle into the eyes.

There have been at least 23 complaints by consumers in relation to this recall, per the FDA release, including:

  • Foreign body in the eye (12)
  • Eye irritation (2)
  • Ocular discomfort (2)
  • Product contamination (2)
  • Superficial injury of eye (2)
  • Eye pain (1)
  • Eye swelling (1)
  • Vision blurred (1)

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