Class I - Dangerous
cGMP deviations
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Chemical contamination: Presence of benzene
Class I - Dangerous
Presence of Particulate Matter
Class I - Dangerous
Chemical contamination: Presence of benzene
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109.
Consumer Product Partners
Class I - Dangerous
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I - Dangerous
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class I - Dangerous
Chemical contamination: presence of benzene
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Denison Pharmaceuticals
Class I - Dangerous
Chemical Contamination: Presence of benzene.
Class I - Dangerous
Chemical Contamination
Alprostadil Container Description: Amber color bottle
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Sigan Industries Group
Class I - Dangerous
Chemical Contamination: Presence of benzene
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Aspen Biopharma Labs Pvt.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Chemical Contamination