Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

FDA recall notice · announced March 14, 2018 · Akorn

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 011037A
Quantity: 31,812 bottles
Status: Terminated
Products in this recall event:
- Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05 (D-0577-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.