Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Other Drugs
π Drugs β’ 3,313 recalls
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
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.
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.
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
Chemical Contamination: Presence of benzene.
Chemical Contamination
Alprostadil Container Description: Amber color bottle
Aspen Biopharma Labs Pvt.
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.
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
Chemical Contamination: Presence of benzene
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Aspen Biopharma Labs Pvt.
CGMP Deviations
Chemical Contamination
Voriconazole Container Description: voriconazole 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.
CGMP Deviations
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product AdrenalinΒΏ (epinephrine injection, USP)
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
The W.S. Badger Company
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
Brands International
CGMP Deviations: lack of adequate release testing.
CGMP Deviations; product intended for quarantine was inadvertently distributed
LABELING: LABEL MIX-UP
LABELING: LABEL MIX-UP