Drug product
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
D-0551-2026
Product summary
- Firm
- AbbVie Inc.
- Event
- Event 99008
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2,736 bottles
- Official record key
drug-enforcement:D-0551-2026
Official wording
Reason: Failed Stability Specifications
Code information: Lot # 402805, 407596, Exp Date: 08/2026.
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications