FDA Recall
Terminated
Historical recordClass III
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
by Teva Pharmaceuticals USA
- Reason
- Failed Stability Specifications
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
by Par Sterile Products LLC
- Reason
- Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
by Akorn, Inc.
- Reason
- Product is being recalled due to low pH value.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 32 count Miss Vickies Multipack Box 44 oz. packaged in flexi…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 30 count Lays Kettle Cooked Multipack Tray 41.25 oz. package…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 30 count Miss Vickies Multipack Tray 41.25 oz. packaged in f…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexib…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- 12 count Lays Kettle Cooked Multipack Sack 10.2 oz packaged…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Frito-Lay, Inc
- Product
- Jalape¿o Flavored Lays Kettle Cooked potato chips and Jalape…
- Reason
- Potential presence of Salmonella
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Treehouse Foods
- Product
- Macaroni & Cheese microwaveable cups sold under the followin…
- Reason
- Products containing cheddar cheese seasoning which may be contaminated with Salmonella.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Our Local Bounty
- Product
- Farming Fish brand Organic Basil Pesto with Watercress, was…
- Reason
- The Organic Basil Pesto with Watercress is recalled because it has the potential to be contaminated with Listeria monocytogenes.
- Published
- May 17, 2017
- Distribution
- distributed in Colorado and Oregon
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hummingbird Wholesale
- Product
- Organic Cocoa-Dusted Chocolate Ginger, packaged and distribu…
- Reason
- Organic Cocoa-Dusted Chocolate Ginger was recalled due to undeclared hazelnuts.
- Published
- May 17, 2017
- Distribution
- distributed in Oregon only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Farmo Foods, Inc.
- Product
- Fresh Mozzarella; No brand name. Shipped in 30 lb. plastic…
- Reason
- Belfiore Cheese was notified by their direct account that cheese received had noticeable metal fragments in the product.
- Published
- May 17, 2017
- Distribution
- One customer in Oregon
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinnacle Foods, LLC
- Product
- Great Value Bread and Butter Chips 24 Fl Oz. Distributed b…
- Reason
- Glass fragments were found in Great Value Bread and Butter Chips.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jimmy's Cookies
- Product
- The Bakery Peanut Butter Chocolate Chunk Cookies, Net Wt. 14…
- Reason
- The Bakery Peanut Butter Chocolate Chunk Cookies may contain undeclared milk.
- Published
- May 17, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Unisea Inc.
- Product
- Frozen Wild Shrimp Burgers, Wild Grill Foods brand, net wt.…
- Reason
- Shrimp Burgers are recalled because the Ingredients statement declared butter, shrimp, cod, and/or Pollock but the Contains statement declared only fish & shellfish.
- Published
- May 17, 2017
- Distribution
- distributed in CA, OR, PA, and WA.
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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