Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
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Prescription Drugs
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Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Losartan 50mg Tablet, 30 count each blister card.
RemedyRepack
Class I - Dangerous
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Aurobindo Pharma USA
Class I - Dangerous
Presence of Particulate Matter: One vial was found to contain a hair.
Class I - Dangerous
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Health Solutions Pharmacy Center Inc
Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class I - Dangerous
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
X-Gen Pharmaceuticals
Class I - Dangerous
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.