Drug Recall
Terminated
Historical recordClass III
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
Discount 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.
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
CVS 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
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
CareOne 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
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
Health 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
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
Rite 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.
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass III
QC 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
by Ohm Laboratories, Inc.
- Reason
- Superpotent Drug: Out Of Specification (OOS) result for Assay.
- Recall initiated
- July 28, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide.
View recall →
Drug Recall
Terminated
Historical recordClass II
WellPatch¿ 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
by The Mentholatum Co.
- Reason
- 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
- Recall initiated
- September 17, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide through Walmart stores.
View recall →
Drug Recall
Terminated
Historical recordClass III
Fenofibric 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 (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA.
by Tribute Pharmaceuticals US Inc.
- Reason
- 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.
- Recall initiated
- October 1, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Fenofibric 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 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.
by Tribute Pharmaceuticals US Inc.
- Reason
- 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.
- Recall initiated
- October 1, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Bravelle 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
by Ferring Pharmaceuticals Inc
- Reason
- Subpotent Drug
- Recall initiated
- September 9, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Metformin 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.
by Actavis Laboratories, FL, Inc.
- Reason
- Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
- Recall initiated
- September 25, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Sedalmex (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.
by Midway Importing, Inc
- Reason
- Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
- Recall initiated
- September 22, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
FUROSEMIDE 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.
by Boehringer Ingelheim Roxane Inc
- Reason
- 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.
- Recall initiated
- September 25, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
FUROSEMIDE 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.
by Boehringer Ingelheim Roxane Inc
- Reason
- 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.
- Recall initiated
- September 25, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Ipratropium 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
by Nephron Pharmaceuticals Corp.
- Reason
- Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
- Recall initiated
- August 21, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Bromfenac 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.
by Apotex Inc.
- Reason
- Lack of Assurance of Sterility: Failed preservative effectiveness testing
- Recall initiated
- August 25, 2015
- Reported by FDA
- October 21, 2015
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Daytrana (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
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
- Recall initiated
- July 27, 2015
- Reported by FDA
- October 14, 2015
- Distribution
- US Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Vytorin (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.
by Merck Sharp & Dohme, Wilson Facility
- Reason
- Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
- Recall initiated
- August 14, 2015
- Reported by FDA
- October 14, 2015
- Distribution
- KY, MS and OH.
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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