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Class II: temporary or reversible health riskTerminated

LGM Pharma Thyroid Powder Recall

Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co

LGM Pharma LLC · Erlanger, KY

Risk level
Class II
Reported by FDA
Dec 19, 2018
Recall ID
D-0296-2019
Check your lot numberHow we source this data

Summary

LGM Pharma recalled Thyroid Powder starting Aug 24, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0296-2019 on Dec 19, 2018. Reason: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Status: Terminated.

Why it was recalled

CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Product description

Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1

Lot numbers, UPCs & expiration codes

Lots: 161101, EXP 11/2/2016; 161201, EXP Nov 2018; 170301, EXP Feb 2019; 170501, Exp Apr 2019; 170701, Exp Jun 2019

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0296-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 24, 2018
FDA report date
Dec 19, 2018
Quantity
1,307 kg
Recall type
Voluntary: Firm initiated
Recalling firm
LGM Pharma LLC

Original FDA data

Every field from FDA enforcement report D-0296-2019, exactly as published.

Show all FDA fields
City
Erlanger
State
KY
Status
Terminated
Country
United States
Event ID
81606
Address
2758 Circleport Dr
Code information
Lots: 161101, EXP 11/2/2016; 161201, EXP Nov 2018; 170301, EXP Feb 2019; 170501, Exp Apr 2019; 170701, Exp Jun 2019
Postal code
41018-1079
Report date
Dec 19, 2018
Product type
Drugs
Recall number
D-0296-2019
Classification
Class II
Recalling firm
LGM Pharma LLC
Product quantity
1,307 kg
Termination date
Sep 11, 2023
Reason for recall
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
Distribution pattern
Nationwide in the USA
Recall initiation date
Aug 24, 2018
Initial firm notification
E-Mail
Center classification date
Dec 12, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0296-2019, published Dec 19, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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