Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, ... — FDA record D-0773-2022

Reported terminated

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 Mar 24, 2022. 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, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Classification
Class II
Recalling firm
Preferred Pharmaceuticals, Inc.
Quantity
528 bottles
Agency-reported status
Terminated
Source record identifier
D-0773-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLots: E1220B, Exp.: 01/31/2023; F0220M, Exp.: 3/31/2023; F2320A, Exp.: 3/31/2023; F3020M, Exp.: 3/31/2023; G0920Q, Exp.: 3/31/2023; C0821M, Exp.: 1/31/2024; J1920, Exp.: 5/31/2023; E2421j, Exp.: 4/30/2024

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the USA.

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
Apr 27, 2022
Recall initiation date
Mar 24, 2022
Center classification date
Apr 15, 2022
Termination date
Oct 25, 2023

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.

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