FDA Recall
Terminated
Historical recordClass II
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.
by Carib Import & Export, Inc.
- Reason
- CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
by West-Ward Pharmaceutical Corp.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
by Warner Chilcott Company LLC
- Reason
- Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
by Warner Chilcott Company LLC
- Reason
- Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
by Warner Chilcott Company LLC
- Reason
- Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
by Hi-Tech Pharmacal Co., Inc.
- Reason
- Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
by Jubilant Cadista Pharmaceuticals Inc.
- Reason
- cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
- Published
- May 8, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
by OPMX, LLC
- Reason
- Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
by OPMX, LLC
- Reason
- Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
by Qualitest Pharmaceuticals
- Reason
- Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
by Mylan Pharmaceuticals Inc.
- Reason
- Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
by Sandoz Incorporated
- Reason
- Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
by Brower Enterprises Inc
- Reason
- Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
by Body Basics Inc
- Reason
- Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
by Lupin Pharmaceuticals Inc.
- Reason
- Discoloration; Product may not meet specifications for color description once reconstituted.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
by Hospira Inc.
- Reason
- Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
by Hospira Inc.
- Reason
- Non-Sterility: Confirmed customer complaint of product contaminated with mold.
- Published
- April 24, 2013
- 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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