FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
by Mckesson Medical Surgical
- Reason
- Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
by Medisca, Inc.
- Reason
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad Spectrum SPF 30+, (Octinoxate 7.725%, Oxybenzone 6.18%, Octisalate 5.15%, Avobenzone 3.09%), Net Wt. 1.8 oz. (51 g) jar, Distributed by Signature Club A, Ltd, Tampa, FL 33609.
by Signature Club A Ltd
- Reason
- Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
by Akorn, Inc.
- Reason
- Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)
by Qinhuangdao Zizhu Pharmaceutical, Co.
- Reason
- cGMP Deviations; lack of quality assurance.
- Published
- April 19, 2017
- Distribution
- Product distributed to NY, TX, SC, CO, M…
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
by Novel Laboratories, Inc.
- Reason
- Chemical Contamination
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
by Citron Pharma Llc
- Reason
- Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
- Published
- April 19, 2017
- 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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