FDA Recall
Terminated
Historical recordClass II
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
by Bayer Health Care LLC
- Reason
- Labeling; Product Contains Undeclared API (Oxybenzone)
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Xcellerator (product not labeled)
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
by Novacare, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
by Reesna, Inc
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
by Novo Nordisk Inc
- Reason
- Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
- Published
- June 15, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
- Published
- June 8, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Published
- June 8, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Published
- June 8, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Published
- June 8, 2016
- 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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