Eyedrops for glaucoma, ocular hypertension recalled nationally by Broward medical company
A Broward medical company is recalling some of its eye drops to reduce glaucoma, saying faulty bottles could cause “adverse events.”
On Thursday, the FDA announced Weston-based Apotex Corp. was voluntarily recalling certain Brimonidine Tartrate Ophthalmic Solution, 0.15% strength, as cracks began to develop on some of the caps of the solution bottles.
The broken cap may imperil sterility and cause negative side effects, the FDA said.
Brimonidine Tartrate Ophthalmic Solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The solution was sold nationally to consumers between April 5, 2022, and Feb. 22, 2023, through wholesalers, distributors, warehousing chains, mail order pharmacies and long-term care pharmacies.
Only six lots of the 5 mL, 10 mL and 15 mL solution bottles are recalled. They are:
▪ Lot number: TJ9848
▪ Lot number: TJ9849
▪ Lot number: TK0258
▪ Lot number: TK5341
▪ Lot number: TK0261
▪ Lot number: TK0262
The lot numbers can be found on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode.
This is the third medical company to recently recall eye drops for faulty products or the possibility of causing severe side effects.
In early February, Global Pharma Healthcare recalled EzriCare and Delsam Pharma Artificial Tears Lubricant Eye Drops, citing what the Centers for Disease Control and Prevention is calling an outbreak of “extensively drug resistant” bacteria in Florida, New York, Texas, California and eight other states.
READ MORE: Death, blindness, eye drops recall: bacterial infections in Florida, Texas, other states
Non-sterility issues that could result in the risk of eye infections and blindness was the cause behind Pharmedica USA recalling some of its Purely Soothing eye drops Friday.
READ MORE: Eye drops used to reduce inflammation are recalled globally. They may be contaminated
Consumers who have the recalled Apotex products can call Inmar Rx Solutions at 1-855-275-1273 to receive a recall/return packet including the Recall Stock Response Form (or go to clsnetlink.com).
Consumers with questions on the recall can call Apotex Corp. by phone at 1-800-706-5575, from 8:30 a.m. to 5 p.m. Monday through Friday, or email UScustomerservice@Apotex.com.
Adverse reactions or quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This story was originally published March 4, 2023 at 6:15 PM.
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