Nearly 40,000 bottles of eye drops used to treat red and itchy eyes have been recalled nationwide in the US due to a “potential contamination” problem, the Food and Drug Administration (FDA) said.
The enforcement report said that Prestige Brand Holdings is voluntarily recalling 39,060 15ml bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops because of a “lack of assurance of sterility.”
The bottles were distributed nationwide, according to the report.
The agency classified the recall as a Class II recall, meaning the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the USA Today reported.
Which eye drops have been recalled?
According to the , the recalled eye drops are 15mL bottles with an expiration date of 30 September 2027. Additional product information is listed below:
Name – CLEAR EYES Maximum Itchy Eye Relief
Size – 0.5 fluid ounces per dropper bottle
Lot Code – 2552A
Expiration date – 30 September 2027
NDC – 67172-999-01
UPC – 6 78112 65920 3
Distributed by – Medtech Products Inc.
Prestige Brand Holdings, which markets over-the-counter products such as Dramamine, Breathe Right nasal strips, and Monistat, among others, did not immediately respond to a USA TODAY request for comment.
What should consumers do?
Consumers are advised not to use the recalled eye drops, as they could be contaminated or cause infection.
While the FDA did not specify in the enforcement report, recalled products can often be returned to the place of purchase. Customers should contact local stores to confirm available options.
Sun Pharma recalls 10 eye drop brands in India
Separately, Sun Pharma Distributors Ltd recalled eye drop brands, including Brinolar, Lotepred, and due to contamination concerns, according to a confidential letter the company issued to distributors on 17 July.
A copy of the letter accessed by ANI stated, “Withdrawal of Product – Depopred2ML, Brinolar (BKC FREE), Brinzotim Eye Drops 5ML BKC FREE, Lotepred-5ML, Lotepred 1% Eye Drops SML, Lotepred LS 0.2%E/D5ML, Lotepred T, Nepalact OD Eye Drops 3ML, Nepalact-Z, Toba-F & Nepalact E/D 5ML.”
“Sun Pharma Distributors Ltd has decided, as a precautionary measure, to discontinue further distribution [of], and withdraw all existing stocks of the above products available in your channel,” the letter stated.
The company recalled the stock and requested that billing for the product cease immediately.
“In this regard, you are requested to immediately cease billing of the above-mentioned product and provide us details of any stock currently held by you,” the company’s letter to distributors read, as per ANI.
It added, “Further, you are requested to send back to us any stocks of the product available with you as well as those received from any sources on priority.”
Sun Pharma spokesperson later told ANI, “Patient safety remains our highest priority. We have taken all necessary steps in the best interest of patients and in accordance with applicable regulatory requirements. Our teams are working diligently to restore the availability of these products so that patients continue to have access to these treatment options.”
