Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by…
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
131 FDA recalls mention Menthol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Menthol.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint…
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box…
Reason CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Reason CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
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