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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65154
Product Type Drugs
Status Ongoing
Recalling Firm Lloyd Inc. of Iowa
City Shenandoah
State IA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-01
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01 Lot #: 1098751, Exp. Mar-13 Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 4,440 Bottles D-432-2013
Lloyd Thyro-Tab 0.050 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. Lot #: HB04712, Exp. Mar-13, HB08112, HC08112, Exp Apr-13, and HC11112 May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 7,681,277 tablets D-433-2013
Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01 Lot #: 1098752, Exp. Mar-13; 1099890, Exp Apr-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 19,787 Bottles D-434-2013
Lloyd Thyro-Tab 0.075 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. Lot #: HC04712, Exp. Mar-13; HD08112, Exp. Apr-13; HE08112, HD11112, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 9,545,718 tablets D-435-2013
Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01 Lot #: 1098967, Exp. Mar-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 12,156 Bottles D-436-2013
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. Lot #: HD04712, Exp. Mar-13; HF08112, Exp Apr-13; HF11112, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 5,767,711 tablets D-437-2013
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. Lot #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 21,019,909 tablets D-438-2013
Lloyd Thyro-Tab 0.112 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. Lot #: HE27211, Exp Apr-13; HE35511, Exp Jul-13; HA04112, Exp Aug-13; HC06212, Exp Sep-12. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 7,614,709 tablets D-439-2013
Lloyd Thyro-Tab 0.125 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. Lot #: HA27811, HC27811, Exp Apr-13; HD35311, HA00512, HB00512, exp Jul-13; HA04412, Exp Aug-13; HD06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 13,460,920 tablets D-440-2013
Lloyd Thyro-Tab 0.137 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. Lot #: HD31411, Exp May-13; HC04112, Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 3,844,402 tablets D-441-2013
Lloyd Thyro-Tab 0.150 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. Lot #: HE27811, HD27811, Exp Apr-13; HC00512, Exp Jul-13; HD04112, HE06212, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 9,575,108 tablets D-442-2013
Lloyd Thyro-Tab 0.175 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. Lot #: HC29411, Exp May-13; HD00512, Exp Jul-13; HA08912, Exp Oct-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 5,768,782 tablets D-443-2013
Lloyd Thyro-Tab 0.200 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. Lot #: HD29411, Exp May-13; HE00512, Exp Jul-13; HF062122, Exp Sep-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 5,771,989 tablets D-444-2013
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 Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 142,103 Bottles D-445-2013
Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01 Lot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 40,311 Bottles D-446-2013
Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01 Lot #: 1095209,1095211, Exp Apr-13; 1097408, 1097731, 1097732, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 77,471 Bottles D-447-2013
Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01. Lot #: 1096372, Exp May-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 12,911 Bottles D-448-2013
Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01. Lot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 61,347 Bottles D-449-2013
Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01 Lot #r: 1095922, Exp May-13; 1097735, Exp Jul-13; 1099892, Exp Oct-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 32,345 Bottles D-450-2013
Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01 Lot #: 1095923, Exp May-13; 1097828, Exp Jul-13. Class II cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. 29,489 Bottles D-451-2013
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