FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass II
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 1, 2022Historical recordClass II
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
by Akorn Inc
- Reason
- Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 29, 2019Historical recordClass I
Asia Food Distributor
- Product
- Nova Salted Biscuit The product comes in a 14.08 ounce, pap…
- Reason
- Product contains undeclared milk.
- Published
- March 27, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 13, 2019Historical recordClass II
Horizon Food Group
- Product
- Ne-Mo's Birthday Cake Square with Buttercream Icing, item 50…
- Reason
- Firm received a complaint of a bird foot found in the baked product.
- Published
- March 27, 2019
- Distribution
- AR, AZ, CA, FL, GA, HI, ID, IL, IN, KY,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 13, 2019Historical recordClass II
Horizon Food Group
- Product
- Ne-Mo's Red Velvet Cake Square with Cream Cheese Icing, item…
- Reason
- Firm received a complaint of a bird foot found in the baked product.
- Published
- March 27, 2019
- Distribution
- AR, AZ, CA, FL, GA, HI, ID, IL, IN, KY,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 13, 2019Historical recordClass II
Horizon Food Group
- Product
- Ne-Mo's Chocolate Cake Square with Cream Cheese Icing, item…
- Reason
- Firm received a complaint of a bird foot found in the baked product.
- Published
- March 27, 2019
- Distribution
- AR, AZ, CA, FL, GA, HI, ID, IL, IN, KY,…
View recall →
FDA Recall
TerminatedTerminated: June 19, 2020Historical recordClass I
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
by Mylan Institutional Inc
- Reason
- Presence of Particulate Matter: particulate matter identified as copper salts
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass III
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
by Lannett Company Inc.
- Reason
- Failed Dissolution Specifications
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 14, 2020Historical recordClass III
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
by AVKARE Inc.
- Reason
- Failed Dissolution Specifications
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 19, 2022Historical recordClass I
Dr. King's Natural Medicine Regional Allergies Hawaii U.S. Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955520620, NDC 57955-5206-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 19, 2022Historical recordClass I
Dr. King's Natural Medicine Good Mood Enhancer Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515029, NDC 57955-8150-2
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 19, 2022Historical recordClass I
Dr. King's Bronchial Care, 59 mL (liquid/liquid), Manufactured by: King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80035774 UPC 357955180425
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 19, 2022Historical recordClass I
Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritique et Articulaire, 59 mL, (liquid/liquid) DIN-HM 80035118 UPC 357955180425
by King Bio Inc.
- Reason
- Microbial contamination
- Published
- March 20, 2019
- 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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