FDA Recall
TerminatedTerminated: November 18, 2020Historical 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
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 10, 2017Historical 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.
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 2, 2016Historical 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.
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 19, 2016Historical 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.
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 19, 2016Historical 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.
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 10, 2017Historical 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
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 15, 2022Historical 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
- Published
- October 21, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 20, 2019Historical 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.
- Published
- October 14, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 4, 2016Historical 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.
- Published
- October 14, 2015
- Distribution
- KY, MS and OH.
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FDA Recall
TerminatedTerminated: January 12, 2016Historical recordClass II
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
by Diabetes Corporation of America dba DCA Pharmacy
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
- Published
- October 14, 2015
- Distribution
- Multiple states
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FDA Recall
TerminatedTerminated: February 15, 2017Historical recordClass III
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
by Apotex Inc.
- Reason
- Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 30, 2016Historical recordClass II
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix (Papaverine/ Aloprostadil/ Phentolamine) Products, 5) All Testosterone Products, 6) All Dexamethasone Products, 7) All Levocarnitine Products, 8) All Hydroxyprogesterone Caproate Products, 9) All Triamcinolone Products, 10) All Betamethasone Sodium Phosphate Products, 11) All Methylprednisolone Acetate Products.
by Medistat RX L.L.C.
- Reason
- Lack of Assurance of Sterility
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 14, 2017Historical recordClass III
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
by VistaPharm, Inc.
- Reason
- Defective Container: Lids on unit dose cups are not fully qualified.
- Published
- October 7, 2015
- Distribution
- U.S. Including: CA, IL, LA, OH, PA, and…
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass III
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
by Guthy-Renker LLC
- Reason
- Subpotent Drug: Salicylic acid is subpotent.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass III
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
by Guthy-Renker LLC
- Reason
- Subpotent Drug: Salicylic acid is subpotent.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass III
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
by Guthy-Renker LLC
- Reason
- Subpotent Drug: Salicylic acid is subpotent.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass III
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
by Guthy-Renker LLC
- Reason
- Subpotent Drug: Salicylic acid is subpotent.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2015Historical recordClass III
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
by Guthy-Renker LLC
- Reason
- Subpotent Drug: Salicylic acid is subpotent.
- Published
- October 7, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 27, 2017Historical recordClass I
PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- Published
- September 30, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 27, 2017Historical recordClass I
PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50
by PharMEDium Services, LLC
- Reason
- Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
- Published
- September 30, 2015
- 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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