FDA Recall
Terminated
Historical recordClass II
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
by Mayne Pharma Inc
- Reason
- Failed Dissolution Specifications.
- Published
- December 6, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications; potential presence of broken tablets.
- Published
- December 6, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reese Pharmaceutical Company
- Product
- Orange Flavor Immune Support Dietary Supplement Effervescent…
- Reason
- The label does not list "Sodium" in the ingredient statement.
- Published
- December 6, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reese Pharmaceutical Company
- Product
- Berry Flavor Immune Support Dietary Supplement Effervescent…
- Reason
- The label does not list "Sodium" in the ingredient statement.
- Published
- December 6, 2017
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
FANTE, Inc., dba Casa Sanchez Foods
- Product
- Casa Sanchez Foods, Spicy Guacamole; Net Wt. 9 oz.. (255 g)…
- Reason
- FDA found Listeria monocytogenes in surveillance sample of guacamole.
- Published
- December 6, 2017
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
FANTE, Inc., dba Casa Sanchez Foods
- Product
- Casa Sanchez Foods, Real Guacamole; Net Wt. 9 oz.. (255 g),…
- Reason
- FDA found Listeria monocytogenes in surveillance sample of guacamole.
- Published
- December 6, 2017
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
by West-Ward Pharmaceuticals Corp.
- Reason
- Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
by Amerisource Health Services
- Reason
- Presence of Foreign Tablets/Capsules.
- Published
- November 29, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
by Leading Pharma, LLC
- Reason
- Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
- Published
- November 29, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Shoreline Fruit, LLC
- Product
- Shoreline Fruit Dark Choc Covered Montmorency Cherries packa…
- Reason
- Shoreline Fruit is voluntarily recalling select Shoreline Fruit bulk and Cherry Bay Orchards branded dark chocolate coated cherry products due to supplier's recall of undeclared allergen milk in dark chocolate.
- Published
- November 29, 2017
- Distribution
- Domestic: AK AL AR AZ CA CO CT DC…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Shoreline Fruit, LLC
- Product
- Dried Dark Chocolate Covered Cherries, The products are pack…
- Reason
- Shoreline Fruit is voluntarily recalling select Shoreline Fruit bulk and Cherry Bay Orchards branded dark chocolate coated cherry products due to supplier's recall of undeclared allergen milk in dark chocolate.
- Published
- November 29, 2017
- Distribution
- Domestic: AK AL AR AZ CA CO CT DC…
View recall →
FDA Recall
Terminated
Historical recordClass III
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
- Published
- November 22, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
by Fagron, Inc
- Reason
- cGMP Deviations: lack of quality assurance at the API manufacturer.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
by Genzyme Corporation
- Reason
- Labeling: Incorrect or Missing Package Insert.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
by Amerisource Health Services
- Reason
- Failed Stability Specifications
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
doTERRA International, LLC
- Product
- Slim & Sassy¿ TrimShake Chocolate, SKU 35200001, 1 lb 5.9…
- Reason
- doTERRA is voluntarily recalling unexpired Slim & Sassy¿ TrimShake - Chocolate and Slim & Sassy¿ TrimShake Vanilla mixes due to an undeclared milk allergen.
- Published
- November 22, 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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