Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Reported: October 9, 2019 Initiated: September 20, 2019 #D-1883-2019
Product Description
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Reason for Recall
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 60,176 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.. Recalled by Akorn, Inc.. Units affected: 60,176 bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-1883-2019.
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