49 FDA recalls mention Diphenhydramine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diphenhydramine.
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…
Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug…
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Reason Microbial Contamination of Non-Sterile Products
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of sterility assurance
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason cGMP deviations: Temperature abuse
Reason CGMP Deviations
Reason cGMP deviations
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason Microbial contamination of non-sterile product
Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R…
Reason Lack of Assurance of Sterility
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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