FDA Recall
Terminated
Historical recordClass III
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).
by Pfizer Inc.
- Reason
- Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gel Spice Co, Inc.
- Product
- 1) Ground Tumeric item #73535 Net Wt 50 lbs Distributed by…
- Reason
- Ground Turmeric may contain excess levels of lead.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
by Sandoz Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
by Actavis Inc
- Reason
- Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01.
by Mckesson Packaging Services
- Reason
- Presence of Foreign Substance: foreign material found in the bulk inventory.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
by Endo Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
by LEO PHARMA INC
- Reason
- Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Versa Marketing
- Product
- Fusia Asian Aspirations Szechuan Stir Fry; A delicious blen…
- Reason
- Product was tested and found positive for Listeria monocytogenes.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex Cholestin. Cholesterol Health. 60 Softgels.
- Reason
- Nu Skin announces a voluntary field action for Pharmanex Cholestin due to undeclared allergen; soy.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex Cortitrol. Cortisol Management. 60 Capsules
- Reason
- Nu Skin announces a voluntary field action for Pharmanex Cortitrol due to undeclared allergen; soy.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nu Skin Enterprises Inc.
- Product
- Pharmanex BioGinkgo. Mental Sharpness. 60 Tablets
- Reason
- Nu Skin announces a voluntary field action for Pharmanex BioGinkgo due to undeclared allergen; wheat.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
McCormick & Co Inc. Spice Mill Plant
- Product
- McCormick & Co., Inc., Stubbs Barbecue. 18oz Best By Date…
- Reason
- McCormick & Co., Inc., has decided to initiated a voluntary recall of there Stubbs Sticky Sweet BBQ Sauce 18oz Bottle. Best By Date of January 17, 2020. Because of a glass bottle defect. The glass defect involves various thickness and defects that may result in chipped or missing glass.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Robert Rothschild Farm LLC
- Product
- Gift Sets with Chocolate Pretzel Dippers
- Reason
- The product is not labeled with an ingredient statement and therefore, does not declare the allergens, soy and wheat.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Robert Rothschild Farm LLC
- Product
- Gift Sets with Pretzel Twists
- Reason
- The product is not labeled with an ingredient statement and therefore, does not declare the allergens, soy and wheat.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
NSE Products, Inc.
- Product
- Pharmanex ageLOC TR90 Protein Boost. Protein Powder. Net wt.…
- Reason
- Nu Skin announces a voluntary field action for Pharmanex ageLOC TR90 Protein Boost due to an undeclared milk allergen.
- Published
- March 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications - low dissolution results at S3 stage.
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications - low dissolution results at S3 stage.
- Published
- March 8, 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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