💊 Drugs 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.
All Recalls
95,050 total recalls in our database
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385 806-647-1741 Dimmitt, TX 79027
McDaniel Life-Line
💊 Drugs Class I - Dangerous
Unapproved new drug
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
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
💊 Drugs 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
💊 Drugs 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.
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
H J Harkins Company Inc
💊 Drugs Class I - Dangerous
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
💊 Drugs 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-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Health Solutions Pharmacy Center Inc
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Auro Pharmacies Inc.
💊 Drugs Class I - Dangerous
Failed pH Specification: product does not meet pH label claim.
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
🏥 Medical Devices Class I - Dangerous
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
🏥 Medical Devices Class I - Dangerous
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over