Drug 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
D-1388-2020
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 86019
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33,343 bottles
- Official record key
drug-enforcement:D-1388-2020
Official wording
Reason: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Code information: Lot 9E52A, exp 04/2021
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination
-
Potency or specification failure
out of specification