Medications & Supplements/Prescription Drugs

Amneal Pharmaceuticals of New York, LLC: Lorazepam Oral Concentrate Recalled Due to Defective Dropper Markings

Agency Publication Date: December 21, 2017

Summary

Amneal Pharmaceuticals is recalling approximately 136,376 bottles of Lorazepam Oral Concentrate, USP (2 mg/mL), a prescription medication used to treat anxiety. The recall was initiated because the included medicine dropper may have measurement markings that are missing, shifted, or printed in the reverse order. This defect can lead to consumers taking the wrong dose of medication. Affected 30 mL bottles were distributed nationwide and include various lot numbers with expiration dates ranging from August 2018 through March 2019.

Risk

Defective measurement markings on the dosing dropper can cause a patient to accidentally ingest too much or too little medication. An overdose of Lorazepam can lead to severe respiratory depression, extreme drowsiness, and potentially fatal consequences, while an underdose may fail to control the medical condition being treated.

What You Should Do

Check your medicine bottle and packaging to see if you have Lorazepam Oral Concentrate, USP, 2 mg/mL in a 30 mL bottle (NDC 65162-687-84).
Verify the lot number and expiration date on your bottle against the affected list: 06876016A, 06876017A, 06876018A (Exp 08/2018); 06876019A, 06876020A, 06876021A, 06876022A (Exp 09/2018); 06876023A (Exp 11/2018); 06876024A, 06876025A (Exp 12/2018); 06877001A, 06877002A (Exp 02/2019); or 06877003A (Exp 03/2019).
If your medication is part of the recall, contact your healthcare provider or pharmacist immediately for guidance on dosing and to obtain a safe replacement.
Return any unused or affected product to your pharmacy to receive a refund.
Contact Amneal Pharmaceuticals of New York, LLC at their Brookhaven facility for further instructions regarding this recall.
For additional questions or to report a problem, 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. Return any unused product to the pharmacy for a refund

How to: Return the affected medication to the place of purchase for a refund and consult a medical professional regarding replacement dosing.

Affected Products

Product: Lorazepam Oral Concentrate, USP, 2 mg/mL (30 mL bottle)

Model:

NDC 65162-687-84

Recall #: D-0120-2018

Lot Numbers:

06876016A (Exp 08/2018)

06876017A (Exp 08/2018)

06876018A (Exp 08/2018)

06876019A (Exp 09/2018)

06876020A (Exp 09/2018)

06876021A (Exp 09/2018)

06876022A (Exp 09/2018)

06876023A (Exp 11/2018)

06876024A (Exp 12/2018)

06876025A (Exp 12/2018)

06877001A (Exp 02/2019)

06877002A (Exp 02/2019)

06877003A (Exp 03/2019)

Date Ranges: Exp 08/2018, Exp 09/2018, Exp 11/2018, Exp 12/2018, Exp 02/2019, Exp 03/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77898

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 136376 bottles

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

Risk

What You Should Do

Check your medicine bottle and packaging to see if you have Lorazepam Oral Concentrate, USP, 2 mg/mL in a 30 mL bottle (NDC 65162-687-84).

Verify the lot number and expiration date on your bottle against the affected list: 06876016A, 06876017A, 06876018A (Exp 08/2018); 06876019A, 06876020A, 06876021A, 06876022A (Exp 09/2018); 06876023A (Exp 11/2018); 06876024A, 06876025A (Exp 12/2018); 06877001A, 06877002A (Exp 02/2019); or 06877003A (Exp 03/2019).

If your medication is part of the recall, contact your healthcare provider or pharmacist immediately for guidance on dosing and to obtain a safe replacement.

Return any unused or affected product to your pharmacy to receive a refund.

Contact Amneal Pharmaceuticals of New York, LLC at their Brookhaven facility for further instructions regarding this recall.

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

Affected Products

Product: Lorazepam Oral Concentrate, USP, 2 mg/mL (30 mL bottle)

Model:

NDC 65162-687-84

Recall #: D-0120-2018

Lot Numbers:

06876016A (Exp 08/2018)

06876017A (Exp 08/2018)

06876018A (Exp 08/2018)

06876019A (Exp 09/2018)

06876020A (Exp 09/2018)

06876021A (Exp 09/2018)

06876022A (Exp 09/2018)

06876023A (Exp 11/2018)

06876024A (Exp 12/2018)

06876025A (Exp 12/2018)

06877001A (Exp 02/2019)

06877002A (Exp 02/2019)

06877003A (Exp 03/2019)

Date Ranges: Exp 08/2018, Exp 09/2018, Exp 11/2018, Exp 12/2018, Exp 02/2019, Exp 03/2019