Medications & Supplements/Prescription Drugs

Mckesson Packaging Services: Ranitidine 150 mg Tablets Recalled for Failed Stability Specifications

Agency Publication Date: March 7, 2018

Summary

McKesson Packaging Services is recalling 17,192 cartons of Ranitidine (generic Zantac) 150 mg tablets because the medication failed stability tests. Stability failure means the drug may not maintain its required strength, quality, and purity throughout its shelf life, which could make the medication less effective for patients. These prescription tablets, manufactured by Amneal Pharmaceuticals, were distributed nationwide in cartons containing 100 unit-dose tablets. Consumers should consult their healthcare professional to ensure they are receiving effective treatment.

Risk

When a medication fails stability specifications, its chemical properties can change or degrade over time. This may lead to a loss of potency, resulting in the patient receiving a lower dose than prescribed, which can prevent the effective management of the condition being treated.

What You Should Do

Check your medication packaging to see if you have Ranitidine Tablets, USP 150 mg in 100-count (10x10) unit-dose cartons with NDC 63739-489-10.
Identify the specific lot number and expiration date on the side or bottom of the carton. Affected lots include 0113064 (Exp. 03/2018), 0114628 (Exp. 08/2018), 0115189 (Exp. 08/2018), and 0115462 (Exp. 09/2018).
If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options.
Return any unused tablets from the affected lots to the pharmacy or place of purchase for a refund and further disposal instructions.
Contact McKesson Packaging Services at their Concord, North Carolina facility for more information regarding this recall.
For additional questions or to report an adverse reaction, 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 your healthcare provider or pharmacist for guidance and return product for a refund.

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

Affected Products

Product: RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10)

Model:

NDC 63739-489-10

Recall #: D-0914-2018

Lot Numbers:

0113064 (Exp. 03/2018)

0114628 (Exp. 08/2018)

0115189 (Exp. 08/2018)

0115462 (Exp. 09/2018)

Date Ranges: Expiration 03/2018, Expiration 08/2018, Expiration 09/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79367

Status: Resolved

Manufacturer: Mckesson Packaging Services

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 17,192 cartons (1,719,200 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 medication packaging to see if you have Ranitidine Tablets, USP 150 mg in 100-count (10x10) unit-dose cartons with NDC 63739-489-10.

Identify the specific lot number and expiration date on the side or bottom of the carton. Affected lots include 0113064 (Exp. 03/2018), 0114628 (Exp. 08/2018), 0115189 (Exp. 08/2018), and 0115462 (Exp. 09/2018).

If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options.

Return any unused tablets from the affected lots to the pharmacy or place of purchase for a refund and further disposal instructions.

Contact McKesson Packaging Services at their Concord, North Carolina facility for more information regarding this recall.

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