June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd.
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando,
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 1
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, F
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 67
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b)
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 670
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only,
Hazard: Lack of assurance of sterility.
June 1, 2022DrugsFDA
GlaxoSmithKline LLC recalls Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 497
Hazard: Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. F
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
June 1, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 1, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 1, 2022DrugsFDA
Eco Lips, Inc recalls Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxat
Hazard: Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
June 1, 2022DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Man
Hazard: Defective Delivery System: customer complaints exceeded respective action limits.
June 1, 2022DrugsFDA
Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Hazard: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
June 1, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, India
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indiana
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
May 25, 2022DrugsFDA
Cardinal Health Inc. recalls Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA
Hazard: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.