ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands…
Reason CGMP Deviations: finished products were manufactured with poor quality water.
155 FDA recalls mention Zinc. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zinc.
Reason CGMP Deviations: finished products were manufactured with poor quality water.
Reason Microbial Contamination of Non-Sterile Products
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…
Reason Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not…
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity…
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity…
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity…
Reason Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary…
Reason Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Reason CGMP Deviations
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Reason Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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