Diclofenac Sodium Topical Solution Recalled for Leaking Bottles
Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.
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 of a drug product. The hazard is a container integrity defect leading to leakage, which is a precautionary quality issue. No illnesses, injuries, or hospitalizations are reported in the source text, and the distribution was limited to physician consignees rather than widespread retail or patient distribution, making this a moderate-severity precautionary recall.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles (NDC 68788-7707-01, Lot E1220B) due to defective containers that fail integrity specifications, resulting in bottles leaking.
The affected product was distributed to five physician consignees located in Connecticut, Florida, and Kansas. A total of 72 bottles were distributed under this recall.
Patients or healthcare providers who have received this product should stop use immediately. If the medication has leaked or the container integrity is compromised, the product should not be used. Patients should contact their healthcare provider for guidance on continued treatment and replacement of the medication.
The recalled product
- Product
- Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Topical Solution
- Hazard
- container-defect
- product-leakage
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 (1)
- Lot #: E1220B
Distribution
Distributed in 3 states:
- CT
- FL
- KS
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