Reported Jul 22, 2020 · Terminated
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:…
Akorn, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only
- Manufactured byAkorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
- Lot codes and dates
Lot 9E52Aexp 04/2021
- Amount recalled
- 33,343 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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