Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
Shoreside Enterprises
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Milbar Laboratories
Class I - Dangerous
Subpotent
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Stability Specifications
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Milbar Laboratories
Class I - Dangerous
Subpotent
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Class I - Dangerous
Failed Stability Specifications
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Milbar Laboratories
Class I - Dangerous
GMP Deviations
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
Class I - Dangerous
Microbial Contamination of Non-sterile Product
Class I - Dangerous
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Altera Handset NDC 83490-0678-05 56 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Xolair 150 mg SDV NDC 50242-0040-62 28 days
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Kroger Specialty Pharmacy
Class I - Dangerous
Lack of Processing Controls.