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Recall Observatory FDA recall evidence

Drug product

Lloyd Thyro-Tab 0.100 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-438-2013

April 01, 2013

Class II

Product summary

Firm
Lloyd Inc. of Iowa
Event
Event 65154
Status
Terminated
Classification
Class II
Quantity
21,019,909 tablets
Official record key
drug-enforcement:D-438-2013

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 #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-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