Recalls / Class III
Class IIID-1388-2020
Product
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
- Affected lot / code info
- Lot 9E52A, exp 04/2021
Why it was recalled
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 33,343 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-12-26
- FDA classified
- 2020-07-14
- Posted by FDA
- 2020-07-22
- Terminated
- 2022-07-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1388-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.