Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Lindane Lotion
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Affected NDC
60432-0833-60
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- NDC code
- 60432-833-60
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0571-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Morton Grove Pharmaceuticals, Inc.
All 2015 recalls
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Other wrong potency / content recalls from 2015
All wrong potency / content recalls
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
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