Drug recall: Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd…
Class II FDA enforcement event 62511. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
cGMP Deviations; does not meet in process specification requirements
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Lloyd Inc. of Iowa started this drug recall on 9 Jul 2012. The firm address in the FDA record is in Shenandoah, IA. FDA put the recall in Class II. FDA event 62511 has 12 product records. The first FDA enforcement report date is 12 Dec 2012. The record gives the status Terminated, with the termination date 14 Nov 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Recalling firm
Lloyd Inc. of Iowa, Shenandoah, IA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-074-2013 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 1,923,887 tablets | Class II | Terminated | 12 Dec 2012 |
| D-075-2013 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 13,692/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
| D-076-2013 | Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 3,826,269 tablets | Class II | Terminated | 12 Dec 2012 |
| D-077-2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 31,252/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
| D-078-2013 | Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 3,813,645 tablets | Class II | Terminated | 12 Dec 2012 |
| D-079-2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 37,827/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
| D-080-2013 | Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 1,924,174 tablets | Class II | Terminated | 12 Dec 2012 |
| D-081-2013 | Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 19,162/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
| D-082-2013 | Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 3,774,541 tablets | Class II | Terminated | 12 Dec 2012 |
| D-083-2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 36,978/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
| D-084-2013 | Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | 1,902,957 tablets | Class II | Terminated | 12 Dec 2012 |
| D-085-2013 | Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | 1,443/100-tablet bottles | Class II | Terminated | 12 Dec 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2012
- 209
- Share of these events in Class II
- 56%
- Product records in this event
- 12Median of the firm: 12
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Apr 2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharma | Drug | Class II | 20 |
| 25 Jul 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Phar | Drug | Class II | 4 |
Official channels
- FDA enforcement report D-074-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 62511. https://recallregister.com/fda/ii/62511/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
- What quantity of product is in FDA event 62511?
- The event has 12 product records. The first record gives this quantity:
1,923,887 tablets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2012 have the same class?
- 56% of the 209 drug events that started in 2012 are in Class II.