US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Daiso Issues Alergy Alert for Prepackaged Snacks

      Summary Company Announcement Date: February 03, 2023 FDA Publish Date: … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

July 27, 2017 By The FDA Leave a Comment

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.

Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, which has been reported with Cyclobenzaprine HCI when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The effects of alcohol, barbiturates, and other CNS depressants may be enhanced, and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Amantadine has a precaution in its prescribing indication about the abrupt discontinuation of the medicine. Missed doses of Amantadine in a few patients with Parkinson’s disease have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. Apace Packaging LLC has not received any reports of adverse events related to this recall.

Cyclobenzaprine HCl 5mg 50ct Unit Dose (NDC# 50268-190-15) is used for the relief of muscle spasms and Amantadine HCl 100mg 50ct Unit Dose (NDC# 50268-069-15) is used for the treatment of Parkinson’s and drug-induced extrapyramidal reactions and the treatment of various viral-based conditions. Both products are packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 cards per carton). The affected lot of Cyclobenzaprine and Amantadine is Lot 16710 with an expiration date of 07/2018. The subject products were fully distributed to R&S Northeast, and then further distributed nationwide.

Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for the return of the product.

Consumers with questions regarding this recall can contact Apace Packaging by 270-434-2722 Monday-Friday (8am – 4pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Daiso Issues Alergy Alert for Prepackaged Snacks

February 3, 2023 By The FDA

Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk

February 3, 2023 By The FDA

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

February 2, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by BTPEIHTD; Sold Exclusively at Amazon.com

February 1, 2023 By The CPSC

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by ChildLikeMe; Sold Exclusively at Amazon.com

February 1, 2023 By The CPSC

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by SGMWVB Brand; Sold Exclusively on Amazon.com

February 1, 2023 By The CPSC

Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

February 1, 2023 By The FDA

B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies

January 31, 2023 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

February 1, 2023 By The FDA

B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies

January 31, 2023 By The FDA

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

January 30, 2023 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Daiso Issues Alergy Alert for Prepackaged Snacks
  • Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk
  • Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
  • Paper Cape Recalls Children’s Pajamas Due to Violation of Federal Flammability Standards and Burn Hazard
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Imported by Betusline Official Apparel; Sold Exclusively on Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by BTPEIHTD; Sold Exclusively at Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by ChildLikeMe; Sold Exclusively at Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by SGMWVB Brand; Sold Exclusively on Amazon.com
  • Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2023 Altrumedia · Terms of Service · Log in