FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Whiskey Hill Smokehouse
- Product
- Elk Jerky, brand Trophy Series, heat treated shelf stable pa…
- Reason
- Elk jerky is recalled due to undeclared soy lecithin.
- Published
- April 26, 2017
- Distribution
- CA, FL, IL, MA, NC, NY, OR, OR, PA, TX,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Whiskey Hill Smokehouse
- Product
- Bison Jerky, brand Trophy Series, heat treated shelf stable…
- Reason
- Bison jerky is recalled due to undeclared soy lecithin.
- Published
- April 26, 2017
- Distribution
- CA, FL, IL, MA, NC, NY, OR, OR, PA, TX,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Whiskey Hill Smokehouse
- Product
- Venison Jerky, brand Trophy Series, heat treated shelf stabl…
- Reason
- Venison jerky is recalled due to undeclared soy lecithin.
- Published
- April 26, 2017
- Distribution
- CA, FL, IL, MA, NC, NY, OR, OR, PA, TX,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Pondini, inc.
- Product
- Pecorino Balze Volteranne DOP Societa Agricola Fattoria Li…
- Reason
- Pecorino Balze Volteranne raw sheeps milk cheese tested positive for Listeria monocytogenes
- Published
- April 26, 2017
- Distribution
- NJ and NY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Advanced Fresh Concepts Corp
- Product
- AFC Edamame Soybeans in Pods, 8 oz , refrigerated, in cardbo…
- Reason
- Product may be contaminated with listeria monocytogenes
- Published
- April 26, 2017
- Distribution
- The products were packaged by AFC Franch…
View recall →
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 →
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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