Recall archive / FDA drug enforcement
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferre... — FDA record D-0278-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Defective container: Out of specification for container integrity leading to bottles leaking.
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 72 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0278-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: E1220B |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 22, 2021
- Recall initiation date
- Nov 29, 2021
- Center classification date
- Dec 13, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.