FDA DrugsClass III
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril...
Published: June 3, 2026Recall ID: D-0551-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Stability Specifications
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | North Chicago |
| State | IL |
| Openfda › Upc | 0311980174101 |
| Openfda › Unii | 8B2807733D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 209002 |
| Openfda › Rxcui › 2 | 562379 |
| Openfda › Spl id | 02594e74-d6cf-40b5-bfb1-c27be33e0e35 |
| Openfda › Brand name | PRED MILD |
| Openfda › Spl set id | 4fcce64a-94ea-4031-ad5a-c4eddc73a910 |
| Openfda › Package ndc › 1 | 11980-174-05 |
| Openfda › Package ndc › 2 | 11980-174-10 |
| Openfda › Product ndc | 11980-174 |
| Openfda › Generic name | PREDNISOLONE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PREDNISOLONE ACETATE |
| Openfda › Manufacturer name | Allergan, Inc. |
| Openfda › Application number | NDA017100 |
| Openfda › Is original packager | true |
| Event id | 99008 |
| Address 1 | 1 N Waukegan Rd |
| Code info | Lot # 402805, 407596, Exp Date: 08/2026. |
| Postal code | 60064-1802 |
| Report date | 20260603 |
| Product type | Drugs |
| Product quantity | 2,736 bottles |
| Reason for recall | Failed Stability Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Initial firm notification | Letter |
| Center classification date | 20260527 |
Overview
- Recalling FirmAbbVie Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide.