Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIDiscount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIICVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIICareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIHealth Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIRite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugOhm Laboratories, Inc.Class IIIQC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
Superpotent Drug: Out Of Specification (OOS) result for Assay.
- 2015-10-21FDA-DrugThe Mentholatum Co.Class IIWellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31074201566
Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section
- 2015-10-21FDA-DrugTribute Pharmaceuticals US Inc.Class IIIFenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofib
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
- 2015-10-21FDA-DrugTribute Pharmaceuticals US Inc.Class IIIFenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
- 2015-10-21FDA-DrugFerring Pharmaceuticals IncClass IIIBravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054, By: Ferring Gmbh, Kiel Germany, NDC 55566-8505-6
Subpotent Drug
- 2015-10-21FDA-DrugActavis Laboratories, FL, Inc.Class IIMetformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
- 2015-10-21FDA-DrugMidway Importing, IncClass IISedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4.
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
- 2015-10-21FDA-DrugBoehringer Ingelheim Roxane IncClass IIIFUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
- 2015-10-21FDA-DrugBoehringer Ingelheim Roxane IncClass IIIFUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
- 2015-10-21FDA-DrugNephron Pharmaceuticals Corp.Class IIIpratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
- 2015-10-21FDA-DrugApotex Inc.Class IIBromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Lack of Assurance of Sterility: Failed preservative effectiveness testing
- 2015-10-14FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
- 2015-10-14FDA-DrugMerck Sharp & Dohme, Wilson FacilityClass IIVytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
- 2015-10-14FDA-DrugDiabetes Corporation of America dba DCA PharmacyClass IISermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
- 2015-10-07FDA-DrugApotex Inc.Class IIIVerapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
- 2015-10-07FDA-DrugMedistat RX L.L.C.Class IIAll Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix (Papaverine/ Aloprostadil/ Phentolamine) Products, 5) All Testosterone Products, 6) All Dexamethasone Products, 7) All Levocarnitine Products, 8) All Hydroxyprogesterone Caproate Products, 9) All Triamcinolone Products, 10)
Lack of Assurance of Sterility
- 2015-10-07FDA-DrugEagle Pharmacy, Inc.Class IILIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
- 2015-10-07FDA-DrugVistaPharm, Inc.Class IIIMETOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Defective Container: Lids on unit dose cups are not fully qualified.
- 2015-10-07FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IProlotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
- 2015-10-07FDA-DrugHartley Medical Center Pharmacy, IncorporatedClass IProlotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
- 2015-10-07FDA-DrugGuthy-Renker LLCClass IIIRodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Subpotent Drug: Salicylic acid is subpotent.
- 2015-10-07FDA-DrugGuthy-Renker LLCClass IIIRodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Subpotent Drug: Salicylic acid is subpotent.
- 2015-10-07FDA-DrugGuthy-Renker LLCClass IIIRodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Subpotent Drug: Salicylic acid is subpotent.
- 2015-10-07FDA-DrugGuthy-Renker LLCClass IIIStop using Rodan & Fields Proactiv compact foundation
Subpotent Drug: Salicylic acid is subpotent.
- 2015-10-07FDA-DrugGuthy-Renker LLCClass IIIStop using Rodan & Fields Proactiv compact foundation
Subpotent Drug: Salicylic acid is subpotent.
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