Why it was recalled
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Product description
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
Lot numbers, UPCs & expiration codes
Lot #: 34770301, exp. date Mar-23; 34770401, exp. date May-23; 12981201, exp. date Nov-23; 13037201, exp. date Dec-23; 13037301, 13647801, exp. date Feb-24; 13722101, exp. date Mar-24; 13980101, 13980001, exp. date Apr-24; 14461701, 14461801, exp. date Jul-24; 14706201, exp. date Aug-24; 14935601, exp. date Oct-24; 5500131A, 5500132A, exp. date Mar-25
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0475-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2023
- FDA report date
- Apr 5, 2023
- Quantity
- 372,938 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0475-2023, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 91802
- Address
- 1400 Atwater Dr
- Code information
- Lot #: 34770301, exp. date Mar-23; 34770401, exp. date May-23; 12981201, exp. date Nov-23; 13037201, exp. date Dec-23; 13037301, 13647801, exp. date Feb-24; 13722101, exp. date Mar-24; 13980101, 13980001, exp. date Apr-24; 14461701, 14461801, exp. date Jul-24; 14706201, exp. date Aug-24; 14935601, exp. date Oct-24; 5500131A, 5500132A, exp. date Mar-25
- Postal code
- 19355-8701
- Report date
- Apr 5, 2023
- Product type
- Drugs
- Recall number
- D-0475-2023
- Classification
- Class II
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Product quantity
- 372,938 bottles
- Termination date
- Nov 8, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 2, 2023
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 24, 2023