Reported Oct 9, 2019 · Terminated
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest,…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd
- byAkorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15
- Lot codes and dates
Lot #: 031908AExp 03/20
- Amount recalled
- 60,176 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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