FDA Recall
Terminated
Historical recordClass III
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
by Sandoz, Inc
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
by Sandoz, Inc
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
by Virtus Pharmaceuticals, Llc
- Reason
- Chemical Contamination: Bottles may contain broken dessicants
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
by Profarma Distributors LLC
- Reason
- CGMP Deviations
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
by Profarma Distributors LLC
- Reason
- CGMP Deviations
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
by Profarma Distributors LLC
- Reason
- CGMP Deviations
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
by Profarma Distributors LLC
- Reason
- CGMP Deviations
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
by Profarma Distributors LLC
- Reason
- CGMP Deviations
- Published
- June 29, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
by Par Pharmaceutical
- Reason
- Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particulate Matter: Glass particulate found in sterile injectable product
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
by Sandoz Inc
- Reason
- Labeling: Incorrect or Missing Package Insert
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Cardboard
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
by Galderma Laboratories, L.P.
- Reason
- Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
by Nostrum Laboratories, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- June 22, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
TruTrim (product not labeled)
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
by Reesna, Inc
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
- Published
- June 15, 2016
- 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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