FDA Recall
Terminated
Historical recordClass II
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India
by Mylan Pharmaceuticals Inc.
- Reason
- Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
by Aurobindo Pharma USA Inc
- Reason
- Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
- Published
- June 5, 2013
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meperidine 100mg/ml MDV, 5ml 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine 2% Inj MDV, 20 ml 30 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,
by Nora Apothecary and Alternative Therapies, Inc.
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
- Published
- June 5, 2013
- 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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