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Recall Enforment Report D-0447-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Specialty Process Labs LLC, originally initiated on 03-01-2024 for the product S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03 The product was recalled due to failed stability specifications. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0447-202403-01-202404-24-2024Class II217 unitsS.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03Failed Stability SpecificationsOngoing
D-0446-202403-01-202404-24-2024Class II26 unitsS.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.Failed Stability SpecificationsOngoing