Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Dermoplast Anesthetic PAIN & ITCH
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
Drug: Menthol
- Recalling firm
- Advantice Health
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1279-2019 · 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 Menthol recalls
See all
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Other recalls by Advantice Health
All 2019 recalls
Class III · Low risk
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
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