Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Drugs Recalls
Prescription and over-the-counter medications
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Morton Grove Pharmaceuticals
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Amerita Specialty Infusion Services
Lack of Assurance of Sterility
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Pine Pharmaceuticals
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Pine Pharmaceuticals
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
Amerisource Health Services
Presence of Particulate Matter
Subpotent Drug
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
Avantor Performance Materials
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Walgreens Infusion Services
Lack of Assurance of Sterility
0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Walgreens Infusion Services
Lack of Assurance of Sterility