Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Drugs Recalls
Prescription and over-the-counter medications
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Caraco Pharmaceutical Laboratories
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Deseo Rebajar
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Caraco Pharmaceutical Laboratories
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
Genesis Pharmaceutical
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
John W Hollis
Presence of Particulate Matter