April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compoundi
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 9
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #1
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional C
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy recalls SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle B
Hazard: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
April 17, 2019DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut
Hazard: 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.
April 17, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear
Hazard: CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
April 17, 2019DrugsFDA
Auro Pharmacies Inc. DBA Central Drugs recalls Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Hazard: Failed pH Specification: product does not meet pH label claim.
April 17, 2019DrugsFDA
RemedyRepack Inc. recalls Losartan 50mg Tablet, 30 count each blister card.
Hazard: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
April 10, 2019DrugsFDA
Akorn, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
April 10, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnolo
Hazard: Labeling: Label mix-up
April 10, 2019DrugsFDA
KRS Global Biotechnology, Inc recalls NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnolo
Hazard: Labeling: Label mix-up
April 10, 2019DrugsFDA
Johnson Matthey Inc. recalls Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 N
Hazard: Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
April 10, 2019DrugsFDA
Pacific Compounding Pharmacy & Consultations Inc recalls Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Hazard: Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
April 10, 2019DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202,
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
April 10, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics L
Hazard: Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
April 10, 2019DrugsFDA
Pfizer Inc. recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials p
Hazard: Presence of Particulate Matter; glass particulates
April 10, 2019DrugsFDA
Pfizer Inc. recalls Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 0
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 10, 2019DrugsFDA
Pfizer Inc. recalls Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 10, 2019DrugsFDA
Pfizer Inc. recalls Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 10, 2019DrugsFDA
Pfizer Inc. recalls Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia &
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 10, 2019DrugsFDA
Pfizer Inc. recalls Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia &
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 10, 2019DrugsFDA
Pfizer Inc. recalls Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia &
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
April 3, 2019DrugsFDA
Ata International Inc recalls Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riversid
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
April 3, 2019DrugsFDA
Ecolab Inc recalls Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 5
Hazard: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
April 3, 2019DrugsFDA
Ecolab Inc recalls Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, M
Hazard: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
April 3, 2019DrugsFDA
Ecolab Inc recalls Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, M
Hazard: Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.