April 22, 2020DrugsFDA
Filltech USA, LLC recalls Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5
Hazard: Microbial contamination of non-sterile products: positive test for yeast and bacteria.
April 22, 2020DrugsFDA
Golden State Medical Supply Inc. recalls Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (
Hazard: CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA,
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, N
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, ND
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, P
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charl
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Po
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, F
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port C
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Char
Hazard: Lack of Processing Control
April 22, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte,
Hazard: Lack of Processing Control