FDA Recall
TerminatedTerminated: June 9, 2014Historical 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
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FDA Recall
TerminatedTerminated: June 9, 2014Historical 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
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FDA Recall
TerminatedTerminated: May 13, 2016Historical 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
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FDA Recall
TerminatedTerminated: December 23, 2013Historical 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
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FDA Recall
TerminatedTerminated: August 22, 2013Historical 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
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FDA Recall
TerminatedTerminated: August 22, 2013Historical 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
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FDA Recall
TerminatedTerminated: January 13, 2014Historical 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
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FDA Recall
TerminatedTerminated: November 3, 2014Historical 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
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FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
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FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
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FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
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FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Sterility Assurance
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
View recall →
FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
by Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Reason
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Published
- May 1, 2013
- Distribution
- CO, GA, MI, and Puerto Rico
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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