Medications & Supplements/Prescription Drugs

West-Ward Columbus Inc: Doxycycline Hyclate Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: August 2, 2018

Summary

West-Ward Columbus Inc. is recalling 58,096 bottles of Doxycycline Hyclate Tablets, USP (100 mg), a prescription antibiotic used to treat various bacterial infections. Approximately 29,048 50-count bottles and 29,048 500-count bottles are affected because the medication failed dissolution specifications, meaning the tablets may not dissolve properly in the body. This defect can prevent the medication from being absorbed correctly, potentially reducing its effectiveness in treating infections. These products were manufactured by West-Ward Pharmaceuticals Corp. and distributed nationwide throughout the United States.

Risk

If the tablets do not dissolve as required, the patient may not receive the full intended dose of the antibiotic, which could lead to treatment failure and allow the bacterial infection to persist or worsen.

What You Should Do

Check your prescription bottles to see if they match the following identifiers: Doxycycline Hyclate Tablets, USP, 100 mg in 50-count bottles (NDC 0143-2112-50) with Lot 71545B and an expiration date of 01/19.
Check for 500-count bottles of Doxycycline Hyclate Tablets, USP, 100 mg (NDC 0143-2112-05) with Lot 71545A and an expiration date of 07/19.
If you have any of the affected tablets, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.
Return any unused portions of the recalled medication to your pharmacy for a refund.
Contact West-Ward Columbus Inc. at 1809 Wilson Rd, Columbus, Ohio, 43228-9579 for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Doxycycline Hyclate Tablets, USP, 100 mg (50-count bottle)

Model:

NDC# 0143-2112-50

Recall #: D-1024-2018

Lot Numbers:

71545B (Expiry date: 01/19)

Date Ranges: 01/19

Product: Doxycycline Hyclate Tablets, USP, 100 mg (500-count bottle)

Model:

NDC# 0143-2112-05

Recall #: D-1025-2018

Lot Numbers:

71545A (Expiry date: 07/19)

Date Ranges: 07/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80364

Status: Resolved

Manufacturer: West-Ward Columbus Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (29,048 bottles (1,452,400 tablets); 29048 500-count bottles (14,524,000 tablets))

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 prescription bottles to see if they match the following identifiers: Doxycycline Hyclate Tablets, USP, 100 mg in 50-count bottles (NDC 0143-2112-50) with Lot 71545B and an expiration date of 01/19.

Check for 500-count bottles of Doxycycline Hyclate Tablets, USP, 100 mg (NDC 0143-2112-05) with Lot 71545A and an expiration date of 07/19.

If you have any of the affected tablets, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if necessary.

Return any unused portions of the recalled medication to your pharmacy for a refund.

Contact West-Ward Columbus Inc. at 1809 Wilson Rd, Columbus, Ohio, 43228-9579 for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Doxycycline Hyclate Tablets, USP, 100 mg (50-count bottle)

Model:

NDC# 0143-2112-50

Recall #: D-1024-2018

Lot Numbers:

71545B (Expiry date: 01/19)

Date Ranges: 01/19

Product: Doxycycline Hyclate Tablets, USP, 100 mg (500-count bottle)

Model:

NDC# 0143-2112-05

Recall #: D-1025-2018

Lot Numbers:

71545A (Expiry date: 07/19)

Date Ranges: 07/19