Class I - Dangerous
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Subpotent; Hydrochlorothiazide at the 9 month time point.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Qualitest Pharmaceuticals
Class I - Dangerous
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class I - Dangerous
Failed Content Uniformity Specifications; at the 18 month time point.
Class I - Dangerous
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Class I - Dangerous
Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Class I - Dangerous
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Hi-Tech Pharmacal Co.
Class I - Dangerous
Failed Stability Specification; product viscosity and or pH are below specification.
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
Airgas Medical Services
Class I - Dangerous
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Class I - Dangerous
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Tower Pharmacy and Compounding
Class I - Dangerous
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Class I - Dangerous
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Sandoz Incorporated
Class I - Dangerous
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Class I - Dangerous
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA
Airgas Medical Services
Class I - Dangerous
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
Fabscout Entertainment
Class I - Dangerous
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Class I - Dangerous
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Healthy Life Chemistry Inc
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Bethel Nutritional Consulting
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.