Recalls / Class III
Class IIID-0577-2018
Product
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
- Affected lot / code info
- Lot: 011037A
Why it was recalled
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
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
- 31,812 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-02-21
- FDA classified
- 2018-03-05
- Posted by FDA
- 2018-03-14
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0577-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.