Prescription Diclofenac Sodium Topical Solution Recalled for Defective Delivery System
Alembic Pharmaceuticals is recalling Diclofenac Sodium Topical Solution USP 2% due to a defective delivery system affecting certain lots. The product was distributed nationwide.
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: This is an FDA Class II recall for a defective delivery system with no reported illnesses or injuries. The hazard is functional rather than contamination-based, making this a precautionary recall.
Plain-English summary
Alembic Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution USP, 2% w/w in 3.8 FL.OZ. (112 grams) bottles due to a defective delivery system.
The defective delivery system may prevent proper functioning or application of the product. The issue affects specific lots of this prescription medication.
The affected product was distributed nationwide in the United States. The recall includes lots 220151, 220152, and 220153, which expired in November 2024. A total of 2,844 units are involved in this recall. The affected NDC is 62332-487-12.
Patients who have this product should contact their pharmacist or healthcare provider. They should not use the affected lots and should return them to their pharmacy or contact the manufacturer for instructions on replacement or reimbursement.
The recalled product
- Product
- DICLOFENAC SODIUM (DICLOFENAC SODIUM)
- Brand
- DICLOFENAC SODIUM
- Manufacturer
- ALEMBIC PHARMACEUTICALS, INC.
- Hazard
- delivery-system-defect
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 (4)
- Lot #: 220151
- 220152
- 220153
- Exp. Date 11/2024
UPCs (1)
- 0362332487127
Distribution
Distributed nationwide across the United States.
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