February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Liothyronine (T3) 80 mcg SR cap
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls Finasteride/Biotin 1 mg/50 mcg
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
February 5, 2020DrugsFDA
MPRX, Inc. dba Medical Park Pharmacy recalls DHEA/Pregnenol One 10.25 MG Cap
Hazard: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
January 29, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA
Hazard: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
January 29, 2020DrugsFDA
Tuscano and Delucia Group (DBA Entropic Labs) recalls Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
Hazard: Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
January 29, 2020DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manuf
Hazard: Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
January 29, 2020DrugsFDA
RemedyRepack Inc. recalls Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Hazard: CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
January 29, 2020DrugsFDA
Preferred Pharmaceuticals, Inc recalls Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 coun
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
Preferred Pharmaceuticals, Inc recalls Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
Denton Pharma, Inc. recalls Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
Denton Pharma, Inc. recalls Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-c
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Compa
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 29, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Hazard: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
January 29, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Hazard: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
January 22, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pa
Hazard: Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
January 22, 2020DrugsFDA
McGuff Compounding Pharmacy Services, Inc. recalls Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vi
Hazard: Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
January 22, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025
Hazard: CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
January 22, 2020DrugsFDA
AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed b
Hazard: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 m
Hazard: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
January 22, 2020DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx o
Hazard: cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
January 22, 2020DrugsFDA
Sigan Industries Inc. recalls Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distribu
Hazard: Microbial contamination of non-sterile product.
January 22, 2020DrugsFDA
Wisconsin Pharmacal Company, LLC recalls Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 6
Hazard: cGMP violations
January 22, 2020DrugsFDA
Letco Medical LLC recalls Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 6
Hazard: Subpotent
January 22, 2020DrugsFDA
Assurance Infusion recalls TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.
January 22, 2020DrugsFDA
Assurance Infusion recalls TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Hazard: Lack of sterility assurance.