FDA Recall
Terminated
Historical recordClass III
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
by Pack Pharmaceuticals
- Reason
- Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
- Published
- July 25, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
by Luitpold Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter
- Published
- July 25, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
by JHP Pharmaceuticals, LLC
- Reason
- Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
- Published
- July 25, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
by Hospira Inc.
- Reason
- Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
- Published
- July 25, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
by Meda Pharmaceuticals Inc.
- Reason
- Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
- Published
- July 25, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
- Published
- July 25, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
by VistaPharm, Inc.
- Reason
- Impurities/Degradation Products: exceeded specification at 3 month stability testing
- Published
- July 18, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
by Kimberly-Clark Corporation
- Reason
- Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- Published
- July 18, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
by Kimberly-Clark Corporation
- Reason
- Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- Published
- July 18, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
by Noven Pharmaceuticals, Inc.
- Reason
- Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
- Published
- July 18, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18
by GlaxoSmithKline Inc
- Reason
- Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
- Published
- July 18, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
- Published
- July 18, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.
by ASTRA ZENECA Lp
- Reason
- Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
- Published
- July 18, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
by Watson Laboratories Inc
- Reason
- Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
by sanofi-aventis US, Inc.
- Reason
- CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
by sanofi-aventis US, Inc.
- Reason
- CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
by Health Plus Incorporated
- Reason
- Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
by Ranbaxy Inc.
- Reason
- Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
- Reason
- Defective Container; damaged blister units
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
by Watson Laboratories Inc
- Reason
- Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- Published
- July 11, 2012
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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