Failed Moisture Limits: Out of specification for water content
Drugs Recalls
Prescription and over-the-counter medications
Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
Washington Homeopathic Products
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
SUN PHARMACEUTICAL INDUSTRIES
Failed Impurities/Degradation Specifications
LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411
Washington Homeopathic Products
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Cosette Pharmaceuticals
CGMP Deviaitons
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
X-Gen Pharmaceuticals
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
Alembic Pharmaceuticals Limited
Labeling: Label-mixup
Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42
Washington Homeopathic Products
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Temperature Abuse
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Crystallization: customer complaints for crystallization in finished product.
Crystallization: customer complaints for crystallization in finished product.
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
Adams.Secret.co
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
Golden State Medical Supply
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
Adams.Secret.co
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Teva Pharmaceuticals USA
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.