FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Stevens Family Bakery & Orchard LLC
- Product
- Pecan Pie Baked whole pies, Baked 1/2 pies & frozen pies, St…
- Reason
- Product contains undeclared milk - label failed to include the components of butter in the ingredient statement.
- Published
- February 14, 2018
- Distribution
- Product was distributed only in OH.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Stevens Family Bakery & Orchard LLC
- Product
- No Sugar Added Pumpkin Pie Baked whole pies, Stevens Bakery…
- Reason
- Product label failed to include the warning statement for aspartame for their No Sugar products.
- Published
- February 14, 2018
- Distribution
- Product was distributed only in OH.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Stevens Family Bakery & Orchard LLC
- Product
- Lemon Pie Baked whole pies, Baked 1/2 pies & Frozen pies, St…
- Reason
- Product contains undeclared wheat and milk.
- Published
- February 14, 2018
- Distribution
- Product was distributed only in OH.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Stevens Family Bakery & Orchard LLC
- Product
- Apple Top Pie Baked whole pies, Stevens Bakery & Orchard, 73…
- Reason
- Product contains undeclared milk - label failed to include the components of butter in the ingredient statement.
- Published
- February 14, 2018
- Distribution
- Product was distributed only in OH.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Stevens Family Bakery & Orchard LLC
- Product
- Apple Streusel Pie - Baked whole/half pies and Frozen pies,…
- Reason
- Product contains undeclared milk - label failed to include the components of butter in the ingredient statement.
- Published
- February 14, 2018
- Distribution
- Product was distributed only in OH.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CHOBANI
- Product
- Chobani Flip Key Lime Crumble - Key Lime Low-Fat Greek Yogur…
- Reason
- Product is recalled because a statement on the overwrap label erroneously states "No Gluten" while the ingredients statement and the Contains statements on both the overwrap label and the flip label on each individual cup declare wheat.
- Published
- February 14, 2018
- Distribution
- distributed in AL, AR, AZ, CA, CO, CT,…
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FDA Recall
Terminated
Historical recordClass I
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
by Baxter Healthcare Corporation
- Reason
- Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
by International Laboratories, LLC
- Reason
- LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
- Published
- February 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
by Fresenius Kabi USA, LLC
- Reason
- Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- Published
- February 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
by AbbVie Inc.
- Reason
- Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- Published
- February 7, 2018
- Distribution
- MS and OH
View recall →
FDA Recall
Terminated
Historical recordClass II
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- February 7, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
by Medline Industries Inc
- Reason
- Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- Published
- February 7, 2018
- 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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