Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Reported: July 22, 2020 Initiated: December 26, 2019 #D-1388-2020
Product Description
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Reason for Recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 33,343 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12. Recalled by Akorn, Inc.. Units affected: 33,343 bottles.
Why was this product recalled? ▼
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 22, 2020. Severity: Low. Recall number: D-1388-2020.
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