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Recall Observatory FDA recall evidence

Drug product

Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

D-437-2013

April 01, 2013

Class II

Product summary

Firm
Lloyd Inc. of Iowa
Event
Event 65154
Status
Terminated
Classification
Class II
Quantity
5,767,711 tablets
Official record key
drug-enforcement:D-437-2013

Official wording

Reason: cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Code information: Lot #: HD04712, Exp. Mar-13; HF08112, Exp Apr-13; HF11112, Exp May-13.

Distribution pattern: The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations