Medications & Supplements/Prescription Drugs

American Health Packaging: Carbamazepine Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: August 15, 2019

Summary

American Health Packaging is recalling approximately 457 cartons of Carbamazepine (400 mg) Extended-Release Tablets because the medication failed to meet dissolution specifications. When a drug fails dissolution tests, it means the tablets may not release the active medication into your body at the correct rate. This prescription drug is primarily used to treat seizures and certain types of nerve pain.

Risk

If the tablets do not dissolve as intended, the patient may receive too much or too little medication, which could lead to a loss of seizure control or unexpected side effects.

What You Should Do

Check your medication packaging to see if you have Carbamazepine, Extended-Release Tablets, USP, 400 mg, in 30-tablet cartons (containing 3 blister cards of 10 doses).
Look for Lot number 181677 with an expiration date of 11/30/2020 located on the carton or blister cards.
Verify the NDC numbers: the NDC on the carton is 68084-562-21 and the NDC on the unit dose blister is 68084-562-11.
Immediately contact your healthcare provider or pharmacist for guidance on how to continue your treatment and to obtain a safe replacement medication.
Contact your pharmacy to return any unused tablets from the affected lot for a refund.
Contact American Health Packaging at their Columbus, Ohio facility for further instructions regarding this recall.
For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Carbamazepine, Extended-Release Tablets, USP, 400 mg (30 Tablets)

Model:

NDC Carton: 68084-562-21

NDC Unit Dose: 68084-562-11

Recall #: D-1821-2019

Lot Numbers:

181677 (Exp 11/30/2020)

Date Ranges: 11/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83559

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 457 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging to see if you have Carbamazepine, Extended-Release Tablets, USP, 400 mg, in 30-tablet cartons (containing 3 blister cards of 10 doses).

Look for Lot number 181677 with an expiration date of 11/30/2020 located on the carton or blister cards.

Verify the NDC numbers: the NDC on the carton is 68084-562-21 and the NDC on the unit dose blister is 68084-562-11.

Immediately contact your healthcare provider or pharmacist for guidance on how to continue your treatment and to obtain a safe replacement medication.

Contact your pharmacy to return any unused tablets from the affected lot for a refund.

Contact American Health Packaging at their Columbus, Ohio facility for further instructions regarding this recall.

For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332.