FDA Recall
TerminatedTerminated: May 7, 2015Historical recordClass II
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
by Sagent Pharmaceuticals Inc
- Reason
- CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
- Published
- June 26, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 13, 2016Historical recordClass III
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
by Hi-Tech Pharmacal Co., Inc.
- Reason
- Subpotent; 24 month stability test station
- Published
- June 26, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 18, 2014Historical recordClass III
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
by Mission Pharmacal Co
- Reason
- Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- Published
- June 26, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 29, 2016Historical recordClass I
Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
by Advance Pharmaceutical Inc
- Reason
- Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness)
- Published
- June 19, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 1, 2019Historical recordClass I
MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
by OLAAX International
- Reason
- Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- Published
- June 19, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 9, 2014Historical recordClass III
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
by Actavis
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 19, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 24, 2013Historical recordClass III
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
by Teva Pharmaceuticals USA, Inc.
- Reason
- Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
- Published
- June 19, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 7, 2014Historical recordClass II
Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
by Sandoz Incorporated
- Reason
- Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
- Published
- June 19, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 1, 2013Historical recordClass III
Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00
by Physicians Total Care, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 24, 2013Historical recordClass III
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01
by Teva Pharmaceuticals USA, Inc.
- Reason
- CGMP Deviation; cotton coil is missing in some packaged bottles
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 26, 2014Historical recordClass III
Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 26, 2014Historical recordClass III
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 26, 2014Historical recordClass III
Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube, NDC 0067-3999-12, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121, (Vertical Pack) and b) packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code: 300673999428.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 26, 2014Historical recordClass III
Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 26, 2014Historical recordClass III
Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc., Parsippany, NJ. (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42; (b) 12 gm (.42 oz), packaged with UPC code: 300673998124 and NDC code: 0067-3998-12; (c) 30 gm (1 oz), packaged with UPC code: 300673998308 and NDC code: 0067-3998-30; (d) 30 gm (1 oz), packaged with UPC code: 300673998339 and NDC code: 0067-3998-33.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- Published
- June 12, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
by THE COMPOUNDING SHOP, INC.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- June 12, 2013
- Distribution
- Florida, California, Minnesota, and Main…
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FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
by THE COMPOUNDING SHOP, INC.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- June 12, 2013
- Distribution
- Florida, California, Minnesota, and Main…
View recall →
FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
by THE COMPOUNDING SHOP, INC.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- June 12, 2013
- Distribution
- Florida, California, Minnesota, and Main…
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FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
by THE COMPOUNDING SHOP, INC.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- June 12, 2013
- Distribution
- Florida, California, Minnesota, and Main…
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FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
by THE COMPOUNDING SHOP, INC.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- June 12, 2013
- Distribution
- Florida, California, Minnesota, and Main…
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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