FDA Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hampton Creek Foods
- Product
- JUST Blueberry Muffin Mix; NET WT 23.3 oz. (1 lb 7.3 oz) 66…
- 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
- IFS Web Bulk Pistachio Raw Shelled 80% Wholes Net Wt. 30 lb.…
- 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
Eastland Food Corporation
- Product
- Euro Custard Cake, Plastic wrapped cardboard container (Net…
- Reason
- The New York Department of Agriculture and Markets tested the Euro Custard Cake an detected that the product contained milk. The label did not declare milk and list it as an allergen on the label. Eastland Food Corporation became aware of these results on June 21 when FDA visited it facility. Eastland Food Corporation performed an investigation into the matter and determine late on June 22 that a single lot (310 cases) of product was missing this information. To this point no adverse incidents have been reported due to the mislabeling. Health risk assessment, people who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected Euro Custard Cakes under the mistaken assumption that it does not contain milk.
- Published
- September 7, 2016
- Distribution
- The cases in the lot were distributed to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hampton Creek Foods
- Product
- JUST Yellow Cake Mix; NET WT 20 z. (1 lb 4oz) 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 Chocolate Chunk Muffin Mix; NET WT 20.8 oz. (1 lb 4.8…
- 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
J&D's Down Home Enterprises, Inc.
- Product
- Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz…
- Reason
- Original Bacon Flavored Seasoning Salt, Big Pig brand, is recalled due to a potential to be contaminated with E. coli O121.
- Published
- September 7, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
International Foodsource, LLC
- Product
- Sam International Bulk Raw Whole Pistachio 80% VP Net Wt. 3…
- 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
International Foodsource, LLC
- Product
- IFS Club Bag Pistachio Raw Shelled 80% Wholes Net Wt. 3 lb.…
- 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 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 →
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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