Allergan has announced a voluntary recall of 7 lots of Combigan (brimonidine tartrate, timolol maleate) and 1 lot of Lumigan (bimatoprost) due to testing results not meeting the regulatory specifications for individual and total impurities. Combigan and Lumigan are ophthalmic solutions indicated for the treatment of glaucoma and ocular hypertension.
The recall applies to Combigan 0.2%/0.5%, 5mL solution with:
- NDC# 0023-9211-05; Lot# 94715; Expiration date: 1/19
- NDC# 0023-9211-05; Lot# 94757; Expiration date: 2/19
- NDC# 0023-9211-05; Lot# 94715A; Expiration date: 1/19
- NDC# 0023-9211-05; Lot# 95297; Expiration date: 3/19
The 2.5mL solution with:
- NDC# 0023-9211-03; Lot# 94659; Expiration date: 2/19
The 10mL solution with:
- NDC# 0023-9211-10; Lot# 95223; Expiration date: 3/19
The 15mL solution with:
- NDC# 0023-9211-15; Lot# 95220; Expiration date: 3/19
The 1 recalled lot of Lumigan 0.01%, 2.5mL, has NDC# 0023-3205-03 and Lot # 92575 with an Expiration date: 6/18.
The Company has stated that the likelihood of adverse events occurring from exposure to the products is “considered unlikely”. The Food and Drug Administration (FDA) has been informed of the recall and retailers with the affected lots are asked to quarantine and return the product.
In the case of any of the affected lots being distributed, the customer should be contacted at the retail level and provided with actions required and contact information for returning the recalled products.
For more information call (800) 433-8871 or visit Allergan.com.