Medications & Supplements/Prescription Drugs

Calcitonin Salmon Nasal Spray Recalled for Subpotency and Impurities

Agency Publication Date: March 24, 2023

Summary

Endo Pharmaceuticals, Inc. is recalling 372,938 bottles of Calcitonin Salmon Nasal Spray (calcitonin-salmon) due to the presence of impurities and the medication being subpotent, meaning it is not as strong as it should be. The medication, which was manufactured by Par Pharmaceutical, failed testing for both known and unknown impurities and did not meet the required levels of active ingredient in specific batches. No incidents or injuries have been reported to date.

Risk

A subpotent drug may not effectively treat the medical condition for which it was prescribed, and high levels of impurities can lead to unexpected side effects or reduced safety. Patients using this spray may not receive the intended therapeutic benefit of the medication.

What You Should Do

This recall affects Calcitonin Salmon Nasal Spray, USP (2200 International Units per mL) sold in 3.7 mL bottles with NDC 49884-161-11.
Identify your medication by checking the lot number and expiration date printed on the bottle or carton. Affected lot numbers include 34770301, 12981201, 13037201, 13722101, and several others. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Calcitonin Salmon Nasal Spray, USP (3.7 mL bottle)by Endo Pharmaceuticals / Par Pharmaceutical

Variants: 2200 International Units per mL, 200 International Units/spray, Rx only

Lot Numbers:

34770301 (Exp Mar-23)

34770401 (Exp May-23)

12981201 (Exp Nov-23)

13037201 (Exp Dec-23)

13037301 (Exp Feb-24)

13647801 (Exp Feb-24)

13722101 (Exp Mar-24)

13980101 (Exp Apr-24)

13980001 (Exp Apr-24)

14461701 (Exp Jul-24)

14461801 (Exp Jul-24)

14706201 (Exp Aug-24)

14935601 (Exp Oct-24)

5500131A (Exp Mar-25)

5500132A (Exp Mar-25)

NDC:

49884-161-11

Manufactured by Par Pharmaceutical, Chestnut Ridge, NY 10977

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91802

Status: Resolved

Manufacturer: Endo Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 372,938 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

What You Should Do

This recall affects Calcitonin Salmon Nasal Spray, USP (2200 International Units per mL) sold in 3.7 mL bottles with NDC 49884-161-11.

Identify your medication by checking the lot number and expiration date printed on the bottle or carton. Affected lot numbers include 34770301, 12981201, 13037201, 13722101, and several others. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Calcitonin Salmon Nasal Spray, USP (3.7 mL bottle)by Endo Pharmaceuticals / Par Pharmaceutical

Variants: 2200 International Units per mL, 200 International Units/spray, Rx only

Lot Numbers:

34770301 (Exp Mar-23)

34770401 (Exp May-23)

12981201 (Exp Nov-23)

13037201 (Exp Dec-23)

13037301 (Exp Feb-24)

13647801 (Exp Feb-24)

13722101 (Exp Mar-24)

13980101 (Exp Apr-24)

13980001 (Exp Apr-24)

14461701 (Exp Jul-24)

14461801 (Exp Jul-24)

14706201 (Exp Aug-24)

14935601 (Exp Oct-24)

5500131A (Exp Mar-25)

5500132A (Exp Mar-25)

NDC:

49884-161-11

Manufactured by Par Pharmaceutical, Chestnut Ridge, NY 10977