June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 5515
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pha
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 2
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialt
Hazard: cGMP deviations: Temperature abuse
June 15, 2022DrugsFDA
Grato Holdings, Inc. recalls Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3
Hazard: Microbial contamination of non-sterile product.
June 15, 2022DrugsFDA
Grato Holdings, Inc. recalls Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket
Hazard: Microbial contamination of non-sterile product.
June 15, 2022DrugsFDA
Grato Holdings, Inc. recalls Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. ND
Hazard: Microbial contamination of non-sterile product.
June 15, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distr
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
June 15, 2022DrugsFDA
US Specialty Formulations LLC recalls B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chl
Hazard: Lack of Assurance of Sterility
June 15, 2022DrugsFDA
US Specialty Formulations LLC recalls Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentow
Hazard: Lack of Assurance of Sterility
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each via
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each via
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containe
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers
Hazard: Failed Impurities/Degradation Specifications.
June 8, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc.,
Hazard: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed b
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Man
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g)
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g)
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Family Dollar Stores, Llc. recalls Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscree
Hazard: cGMP deviations: product stored outside of labeled temperature requirements.
June 8, 2022DrugsFDA
Strides Pharma Inc. recalls Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101,
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 8, 2022DrugsFDA
Strides Pharma Inc. recalls Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101,
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 8, 2022DrugsFDA
Strides Pharma Inc. recalls Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101,
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 8, 2022DrugsFDA
Direct Rx recalls Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceutica
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
June 8, 2022DrugsFDA
Vi-Jon, LLC recalls Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouth
Hazard: Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.