FDA Recall
Completed
Historical recordClass III
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Cross contamination with other products
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Cross contamination with other products
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
by Tailstorm Health INC
- Reason
- Subpotent Drug: reduced efficacy for epinephrine
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Cross contamination with other products.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Cross contamination with other products.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc
by Equibal Inc
- Reason
- CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
by SYNCHRONICITY SPA INC, DBA SUNTE
- Reason
- CGMP Deviations
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
by SYNCHRONICITY SPA INC, DBA SUNTE
- Reason
- Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
fgf brands, inc
- Product
- Bakeshop Chocolate Chip Muffin 4 count, in clear plastic cla…
- Reason
- Undeclared Walnut
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
C. Krueger Finest Baked Goods
- Product
- C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic…
- Reason
- No ingredient statement on the label.
- Published
- July 17, 2024
- Distribution
- Alabama, Alaska, Arizona, Arkansas, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
C. Krueger Finest Baked Goods
- Product
- C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookie…
- Reason
- No ingredient statement on the label.
- Published
- July 17, 2024
- Distribution
- Alabama, Alaska, Arizona, Arkansas, Cali…
View recall →
FDA Recall
Ongoing
Historical recordClass I
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
by Integrity Products
- Reason
- Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
by Integrity Products
- Reason
- Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent drug: out of specification results
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
by Trigen Laboratories
- Reason
- Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- 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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