FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hampton Creek Foods
- Product
- JUST Cinnamon Roll Coffee Cake Mix; NET WT 26.9 oz. (1 lb 1…
- Reason
- Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
International Foodsource, LLC
- Product
- Valued Natural Raw Pistachio Kernels Net Wt 5 oz. (141 g) I…
- Reason
- Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hampton Creek Foods
- Product
- JUST White Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567 g); UPC…
- Reason
- Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hampton Creek Foods
- Product
- JUST Devil's Food Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567…
- Reason
- Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
by Teva North America
- Reason
- Superpotent drug: Out of specification test result for assay during stability testing.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
by Akorn, Inc.
- Reason
- Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY
by Exact-Rx Inc
- Reason
- Crystallization; complaints received by the manufacturer of crystals forming in product
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
by Stratus Pharmaceuticals Inc
- Reason
- Crystallization; Complaints that cream appears to have crystallized
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
by Talon Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
by Talon Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mondelez International
- Product
- Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snack…
- Reason
- Teddy Graham Cub Snacks were produced using Grain Craft Flour containing peanut residue.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
La Torre Foods Usa, Inc.
- Product
- la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz…
- Reason
- Calcium caseinate is declared on the label, but milk is not listed.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Montana Flour & Grains, Inc
- Product
- 100% Organic Spelt Flour, packaged in 10 lbs., 25 lbs. and…
- Reason
- Organic Spelt Flour is recalled because label does not declare wheat.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Montana Flour & Grains, Inc
- Product
- 100% Organic Unbleached White Flour, packaged in 10 lbs., 2…
- Reason
- Organic Unbleached White Flour is recalled because label does not declare wheat.
- Published
- August 31, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Montana Flour & Grains, Inc
- Product
- 100% Organic Spelt Grain, packaged in 10 lbs., 25 lbs. and…
- Reason
- Organic Spelt Grain is recalled because label does not declare wheat.
- Published
- August 31, 2016
- 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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