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Showing 15,341–15,360 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass III
Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05
by Novartis Pharmaceuticals Corp.
Reason
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05
by Novartis Pharmaceuticals Corp.
Reason
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer Labs; Division of Pfizer Inc., New York, NY 10017.
by Agila Specialties Private Ltd.
Reason
Presence of Particulate Matter: Potential for small black particles to be present in individual vials, the potential for missing lot number and/or expiry date on the outer carton and the potential for illegible/missing lot number and expiry on individual vials.
Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
by American Lifestyle.Com
Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.
Recall initiated
April 30, 2013
Reported by FDA
April 16, 2014
Distribution
Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman.
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
by Slim Beauty USA
Reason
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
by Zions RX Formulations Services LLC dba RX Formuations Serv.
Reason
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
by Zions RX Formulations Services LLC dba RX Formuations Serv.
Reason
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
by Zions RX Formulations Services LLC dba RX Formuations Serv.
Reason
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.
by Terra-Medica Inc.
Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.
by Terra-Medica Inc.
Reason
Penicillin Cross Contamination.
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2.
by Terra-Medica Inc.
Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1.
by Terra-Medica Inc.
Reason
Penicillin Cross Contamination
Recall initiated
March 3, 2014
Reported by FDA
April 16, 2014
Distribution
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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