FDA Recall
Terminated
Historical recordClass III
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
by Allergan Sales, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.
by Genzyme Corporation
- Reason
- Labeling: Incorrect or Missing Package Insert.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
by Amerisource Health Services
- Reason
- Failed Stability Specifications
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
doTERRA International, LLC
- Product
- Slim & Sassy¿ TrimShake Chocolate, SKU 35200001, 1 lb 5.9…
- Reason
- doTERRA is voluntarily recalling unexpired Slim & Sassy¿ TrimShake - Chocolate and Slim & Sassy¿ TrimShake Vanilla mixes due to an undeclared milk allergen.
- Published
- November 22, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
doTERRA International, LLC
- Product
- Slim & Sassy¿ TrimShake Vanilla, SKU 35180001, 1 lb 5.9 oz,…
- Reason
- doTERRA is voluntarily recalling unexpired Slim & Sassy¿ TrimShake - Chocolate and Slim & Sassy¿ TrimShake Vanilla mixes due to an undeclared milk allergen.
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Turbinado Almonds w/ Sea Salt packaged in :…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Coffee beans packaged in Bulk 4 oz. Plasti…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Cranberries packaged in: Bulk 3.5 oz. Pl…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Aurora Brand Dark Chocolate Cherries packaged in: 8.5 oz.…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Aurora Products, Inc.
- Product
- Dark Chocolate Almonds packaged in: 4 oz. Plastic Pouch,…
- Reason
- Product contains undeclared milk
- Published
- November 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
by Dr. Reddy's Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
- Published
- November 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
by Purdue Pharma, LP
- Reason
- Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
- Published
- November 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
21ST CENTURY SNACK FOODS
- Product
- 21st CENTURY SNACK FOODS DARK CHOCOLATE ALMONDS Roasted Almo…
- Reason
- Product contains undeclared milk.
- Published
- November 15, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
by SCA Pharmaceuticals, LLC
- Reason
- Lack Of Assurance Of Sterility.
- Published
- November 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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