Recalls / Class II

Class IID-445-2013

Product

Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01

Affected lot / code info

Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13.

Why it was recalled

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

Recalling firm

Firm

Lloyd Inc. of Iowa

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

604 W Thomas Ave, N/A, Shenandoah, Iowa 51601-1744

Distribution

Quantity

142,103 Bottles

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.

Timeline

Recall initiated

2013-04-01

FDA classified

2013-05-21

Posted by FDA

2013-05-29

Terminated

2014-05-08

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-445-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.