FDA Recall
Ongoing
Historical recordClass II
Betamethasone Phosphate/Acetate 6 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Betamethasone Sodium Phosphate 12 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Atropine Sulfate 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
by Fresenius Kabi USA, LLC
- Reason
- Failed Impurities/Degradation Specification
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: visible particles were identified floating in the primary container.
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
by Fresenius Kabi USA, LLC
- Reason
- Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67
by Teva Pharmaceuticals USA, Inc.
- Reason
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
by Pfizer Inc.
- Reason
- Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
- Published
- July 10, 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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