FDA Recall
Terminated
Historical recordClass II
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
by Assurance Infusion
- Reason
- Lack of sterility assurance.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
by AVKARE Inc.
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
- Published
- January 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
by Idelle Labs
- Reason
- Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reichel Foods Inc.
- Product
- Pro2Snax To The Max snack tray containing Sweet Gala Apples,…
- Reason
- Products are being recalled due to Listeria monocytogenes contamination.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reichel Foods Inc.
- Product
- Pro2Snax To The Max snack tray containing Sliced Apples, Har…
- Reason
- Products are being recalled due to Listeria monocytogenes contamination.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Butterscotch Pudding Organic Dairy Free,…
- Reason
- Product is recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Vanilla Pudding Organic Dairy Free, Item…
- Reason
- Product recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Chocolate Pudding Organic Dairy Free, It…
- Reason
- Product recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
by Akorn, Inc.
- Reason
- Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
by Natures Rx
- Reason
- Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
by American Health Packaging
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
by Spectrum Laboratory Products
- Reason
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- 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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