Pred Mild prednisolone eye suspension failed stability specifications
Pred Mild prednisolone acetate ophthalmic suspension 0.12% is being recalled after failing stability specifications. 2,736 bottles are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for an out-of-specification stability result, which the rubric places in the 1-2 band; a product-quality failure rather than a cosmetic issue puts it at Moderate.
Plain-English summary
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL sterile, from Allergan, Inc., an AbbVie company, NDC 11980-174-10, is being recalled. The action covers 2,736 bottles.
The stated reason is failed stability specifications. Stability testing confirms that a product stays within its approved specification across its shelf life. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
Affected lots are 402805 and 407596, expiry 08/2026. Distribution was US nationwide.
This is a prescription medicine. Patients should not stop a prescribed treatment without medical advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- PRED MILD (PREDNISOLONE ACETATE)
- Brand
- PRED MILD
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Ophthalmic suspension
- Affected units
- 2,736
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 402805
- 407596
- Exp Date: 08/2026.
UPCs (1)
- 0311980174101
Distribution
Distributed nationwide across the United States.
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