FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Methylcobalamin and Folic Acid 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
Cyanocobalamin (CMP) 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
Triamcinolone Hexacetonide 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
Betamethasone 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 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
Methylprednisolone Acetate 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
TriMix Standartd (PGE Stock Sol'n) 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: December 5, 2013Historical 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
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FDA Recall
TerminatedTerminated: February 26, 2014Historical 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
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FDA Recall
TerminatedTerminated: November 14, 2013Historical 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
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FDA Recall
TerminatedTerminated: April 19, 2017Historical recordClass II
Trimix 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: June 5, 2013Historical 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
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FDA Recall
TerminatedTerminated: September 11, 2013Historical 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
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FDA Recall
TerminatedTerminated: August 21, 2015Historical 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
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FDA Recall
TerminatedTerminated: August 21, 2015Historical 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
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FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened
- 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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