Class I - Dangerous
Lack of Processing Controls.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
Lack of Sterility Assurance.
Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135
SELECT DISTRIBUTIONS
Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class I - Dangerous
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Class I - Dangerous
Failed Stability Specifications: Out of specification for viscosity.
Class I - Dangerous
Lack of Sterility Assurance.