FDA Recall
Terminated
Historical recordClass II
Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 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
Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 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
Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 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
Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 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
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 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
Trimix Inj 4.25ml Form MDV Penile Injection, 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
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 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
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 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
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 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
Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 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
PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 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
PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 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
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 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
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 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
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 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
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 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
Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 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
Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,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
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 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 III
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
- Published
- May 29, 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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