Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
Reported: January 25, 2023 Initiated: October 13, 2022 #D-0150-2023
Product Description
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
Reason for Recall
CGMP Deviations:
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 163,996 bottles
- Distribution
- Nationwide in the USA
- Location
- Gurnee, IL
Frequently Asked Questions
What product was recalled? ▼
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05. Recalled by Akorn, Inc.. Units affected: 163,996 bottles.
Why was this product recalled? ▼
CGMP Deviations:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0150-2023.
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