Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Other Drugs
💊 Drugs • 3,200 recalls
CGMP Deviations
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
SYNCHRONICITY SPA INC
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
CGMP deviations
CGMP deviations
CGMP deviations
CGMP deviations
CGMP Deviations and Presence of Particulate Matter: Glass
CGMP deviations
CGMP deviations
CGMP deviations
CGMP deviations
Sub-potent Drug
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0
Consumer Product Partners
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Denison Pharmaceuticals
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.