February 13, 2019DrugsFDA
Natures Rx recalls the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
February 13, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles,
Hazard: Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
February 13, 2019DrugsFDA
US Pharmaceuticals Inc. recalls Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14)
Hazard: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
February 13, 2019DrugsFDA
US Pharmaceuticals Inc. recalls Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd
Hazard: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
February 13, 2019DrugsFDA
US Pharmaceuticals Inc. recalls Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Ind
Hazard: GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
February 13, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays,
Hazard: Defective Container: Potential for broken glass in the neck area of the glass bottles.
February 6, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC
Hazard: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
February 6, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryl
Hazard: CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
February 6, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries,
Hazard: Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. W
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Wo
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. W
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Wayn
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
Duren Health Mart Pharmacy recalls Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods
Hazard: Lack of Processing Controls.
February 6, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Hazard: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
February 6, 2019DrugsFDA
Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest
Hazard: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only Manufactured by: Zhejiang Huahai Pharmace
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmac
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
February 6, 2019DrugsFDA
Prinston Pharmaceutical Inc recalls Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhe
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 30, 2019DrugsFDA
Advanced Pharma Inc. recalls HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Steri
Hazard: Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
January 30, 2019DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina
Hazard: Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
January 30, 2019DrugsFDA
LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Hazard: Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
January 30, 2019DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind.
Hazard: Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
January 30, 2019DrugsFDA
Happy Together, Inc. recalls 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965
Hazard: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
January 30, 2019DrugsFDA
Bound Tree Medical, LLC recalls Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle,
Hazard: Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
January 30, 2019DrugsFDA
Bound Tree Medical, LLC recalls Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tr
Hazard: Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
January 30, 2019DrugsFDA
Bound Tree Medical, LLC recalls curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcoho
Hazard: Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.