FDA Recall
Terminated
Historical recordClass II
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
by Forest Pharmaceuticals Inc
- Reason
- Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.
by Oasis Medical Inc
- Reason
- Labeling: Missing Label; The label on the immediate bottle is missing.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
by Tendex
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466
by Tendex
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
by SigmaPharm Laboratories LLC
- Reason
- Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
by Zydus Pharmaceuticals USA Inc
- Reason
- Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System; defective valve
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
by Herbal Give Care Llc
- Reason
- Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
by Pfizer Us Pharmaceutical Group
- Reason
- Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
by HUMAN SCIENCE FOUNDATION
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
by Ben Venue Laboratories Inc
- Reason
- Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
by First Aid Only Inc
- Reason
- First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
by Pain Free By Nature
- Reason
- Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
- Published
- May 21, 2014
- 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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