Reported Apr 5, 2023 · Terminated
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7…
Endo Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endo Pharmaceuticals, Inc. · 1400 Atwater Dr · Malvern, PA · 19355-8701
Is this the product you have?
- Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only
- Manufactured byPar Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11
- Lot codes and dates
Lot #: 34770301exp. date Mar-2334770401exp. date May-2312981201exp. date Nov-2313037201exp. date Dec-231303730113647801exp. date Feb-2413722101exp. date Mar-241398010113980001exp. date Apr-241446170114461801exp. date Jul-2414706201exp. date Aug-2414935601exp. date Oct-245500131A5500132Aexp. date Mar-25
- Amount recalled
- 372,938 bottles
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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