Allergan is recalling two glaucoma medications because laboratory testing found that the products did not meet the regulatory specifications for individual and total impurities. The recall involves seven lots of Combigan (brimoidine tartrate and timolol maleate) and one lot of Lumigan (bimatoprost). Both drugs are ophthalmic solutions used to treat glaucoma and ocular hypertension.
Specifically, the recall includes the Combigan 0.2%/0.5%, 5 mL 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 2.5 mL solution with:
- NDC# 0023-9211-03; Lot# 94659; Expiration date: 2/19
The 10 mL solution with:
- NDC# 0023-9211-10; Lot# 95223; Expiration date: 3/19
The 15 mL solution with:
- NDC# 0023-9211-15; Lot# 95220; Expiration date: 3/19
And, the Lumina 0.01%, 2.5 mL with:
- NDC# 0023-3205-03 and Lot # 92575 with an Expiration date: 6/18
Allergan says that the chances that anyone using this drug would experience an adverse event related to the recall is “considered unlikely.” The company has informed the Food and Drug Administration (FDA) of this action and told retailers with affected lots to quarantine and return the product.
Any adverse events related to use of this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.