Class I - Dangerous
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Class I - Dangerous
Superpotent Drug: Salicylic acid content is above the firm's specification.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class I - Dangerous
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class I - Dangerous
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
AuroMedics Pharma
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class I - Dangerous
Failed Impurities/Degradation Specifications
Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Coast Quality Pharmacy, LLC
Class I - Dangerous
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class I - Dangerous
Discoloration: Product complaints of discoloration after reconstitution of vials.
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
SCA Pharmaceuticals
Class I - Dangerous
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Coast Quality Pharmacy, LLC
Class I - Dangerous
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Amneal Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Coast Quality Pharmacy, LLC
Class I - Dangerous
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Coast Quality Pharmacy, LLC
Class I - Dangerous
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.