Class I - Dangerous
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
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Prescription Drugs
💊 Drugs • 12,141 recalls
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
Valeant Pharmaceuticals North America
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Martin Avenue Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Bacteriostatic water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Martin Avenue Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Martin Avenue Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Martin Avenue Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Class I - Dangerous
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
American Health Packaging
Class I - Dangerous
Subpotent; 6 month stability time point
Class I - Dangerous
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
Forest Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specification; at the 6-month stability time point
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
Aidarex Pharmaceuticals
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
Zee Medical Products
Class I - Dangerous
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
American Family Pharmacy
Class I - Dangerous
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Class I - Dangerous
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Zydus Pharmaceuticals USA
Class I - Dangerous
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Class I - Dangerous
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
Valeant Pharmaceuticals International
Class I - Dangerous
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Valeant Pharmaceuticals North America
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset