Key takeaways:
- BRS Analytical Companies initiated a voluntary recall of 5 ophthalmic merchandise.
- Shoppers ought to cease utilizing these merchandise.
Editor’s observe: This can be a creating information story. Please test again quickly for updates.
An synthetic tear resolution is one among 5 ophthalmic merchandise now underneath recall attributable to lapses in manufacturing processes, in accordance with the FDA.
The voluntary recollects have been initiated by BRS Analytical Companies following an FDA audit that exposed deviations from the company’s present good manufacturing apply rules and a “lack of assurance of sterility.” The merchandise have been provided by the medical distributor AvKARE.
Any well being hazards ensuing from these points usually are not presently recognized, in accordance with an announcement from AvKARE. The FDA designated the recollects as class II, indicating potential “short-term or medically reversible antagonistic well being penalties.”
The recalled merchandise are:
- 13,872 circumstances of synthetic tears ophthalmic resolution (NDC 50268-043-15);
- 1,610 circumstances of carboxymethylcellulose sodium ophthalmic gel 1% (NDC 50268-066-15);
- 32,876 circumstances of carboxymethylcellulose sodium ophthalmic resolution (NDC 50268-068-15);
- 13,104 circumstances of lubricant eye drops resolution (NDC 50268-126-15); and
- 14,333 circumstances of polyvinyl alcohol ophthalmic resolution (NDC 50268-678-15).
The recalled merchandise have been shipped between Might 26, 2023, and April 21, 2025, and will not be used. Shoppers who’ve these merchandise can full AvKARE’s recall type and return it to the corporate by fax or e-mail. The merchandise can then be mailed again to AvKARE.
BRS Analytical Companies is an impartial contract testing laboratory based mostly in St. Louis, in accordance with an archived model of its web site. The web site not exists on the time of publication.
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