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 II
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
by Aidarex Pharmaceuticals LLC
- Reason
- Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
- Published
- June 15, 2016
- Distribution
- U.S. including: CA, ND, PA, TN
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 →
FDA Recall
Terminated
Historical recordClass II
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
by Bayer Health Care LLC
- Reason
- Labeling; Product Contains Undeclared API (Oxybenzone)
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Xcellerator (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
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
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
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
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 →
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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