Reported Mar 30, 2022 · Terminated
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA…
Teligent Pharma, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310
Is this the product you have?
- Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only
- Manufactured forSOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05
- Lot codes and dates
- Batch
15384Exp. 3/31/202315646Exp. 5/31/202315971Exp. 9/30/20231620616226Exp. 11/30/202316268Exp. 12/31/20231634216343Exp. 1/31/20241650316504Exp. 3/31/202416632Exp. 4/30/20241671516731Exp. 5/31/2024
- Batch
- Amount recalled
- 36,018 bottles
This recall covers 37 products
The agency filed one notice per product. You are reading one of them; the other 36 are below.
24 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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