Class II
Terminated
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
- Company
- Akorn, Inc.
- Recall Initiated
- September 20, 2019
- Posted
- October 9, 2019
- Recall Number
- D-1883-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,176 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: 031908A, Exp 03/20
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