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Class II: temporary or reversible health riskTerminated

Lannett Ranitidine Syrup Recall

Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed…

Lannett Company, Inc. · Philadelphia, PA

Risk level
Class II
Reported by FDA
Nov 20, 2019
Recall ID
D-0309-2020
Check your lot numberHow we source this data

Summary

Lannett recalled Lannett Ranitidine Syrup starting Oct 28, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0309-2020 on Nov 20, 2019. Reason: CGMP Deviations: Presence of NDMA impurity detected in product. Status: Terminated.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Product description

Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80

Lot numbers, UPCs & expiration codes

1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020 1646A 02/2020 1647A 02/2020 1668A 03/2020 1669A 03/2020 1670A 03/2020 1708A 03/2020 1709A 04/2020 1710A 04/2020 1729A 04/2020 1730A 04/2020 1731A 04/2020 1757A 05/2020 1758A 05/2020 1759A 05/2020 1773A 06/2020 1774A 06/2020 1989A 12/2020 1794A 06/2020 1795A 06/2020 1796A 06/2020 1817A 06/2020 1818A 07/2020 1819A 07/2020 1840A 08/2020 1840B 08/2020 1841A 08/2020 1842A 08/2020 1863A 08/2020 1864A 09/2020 1865A 09/2020 1899A 10/2020 1900A 10/2020 1901A 10/2020 1910A 10/2020 1911A 10/2020 1912A 10/2020 1918A 10/2020 1919A 10/2020 1920A 10/2020 1925A 10/2020 1926A 10/2020 1927A 10/2020 1977A 12/2020 1978A 12/2020 1979A 12/2020 1990A 12/2020 1991A 12/2020 1998A 01/2021 1999A 01/2021 2000A 01/2021 2019A 01/2021 2020A 01/2021 2065A 03/2021 2066A 03/2021 2067A 03/2021 2071A 03/2021 2072A 03/2021 2073A 03/2021 2076A 03/2021 2077A 03/2021 2078A 03/2021 2126A 05/2021 2127A 05/2021 2128A 05/2021 2164A 06/2021 2165A 06/2021 2166A 06/2021 2179A 06/2021 2180A 07/2021 2181A 07/2021 2214A 08/2021 2215A 08/2021 2216A 08/2021

Where it was sold

Nationwide

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-0309-2020
Classification
Class II
Status
Terminated
Recall initiated
Oct 28, 2019
FDA report date
Nov 20, 2019
Quantity
683,149 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Lannett Company, Inc.

Original FDA data

Every field from FDA enforcement report D-0309-2020, exactly as published.

Show all FDA fields
City
Philadelphia
State
PA
Status
Terminated
Country
United States
Event ID
84149
Address
9000 State Rd
Code information
1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020 1646A 02/2020 1647A 02/2020 1668A 03/2020 1669A 03/2020 1670A 03/2020 1708A 03/2020 1709A 04/2020 1710A 04/2020 1729A 04/2020 1730A 04/2020 1731A 04/2020 1757A 05/2020 1758A 05/2020 1759A 05/2020 1773A 06/2020 1774A 06/2020 1989A 12/2020 1794A 06/2020 1795A 06/2020 1796A 06/2020 1817A 06/2020 1818A 07/2020 1819A 07/2020 1840A 08/2020 1840B 08/2020 1841A 08/2020 1842A 08/2020 1863A 08/2020 1864A 09/2020 1865A 09/2020 1899A 10/2020 1900A 10/2020 1901A 10/2020 1910A 10/2020 1911A 10/2020 1912A 10/2020 1918A 10/2020 1919A 10/2020 1920A 10/2020 1925A 10/2020 1926A 10/2020 1927A 10/2020 1977A 12/2020 1978A 12/2020 1979A 12/2020 1990A 12/2020 1991A 12/2020 1998A 01/2021 1999A 01/2021 2000A 01/2021 2019A 01/2021 2020A 01/2021 2065A 03/2021 2066A 03/2021 2067A 03/2021 2071A 03/2021 2072A 03/2021 2073A 03/2021 2076A 03/2021 2077A 03/2021 2078A 03/2021 2126A 05/2021 2127A 05/2021 2128A 05/2021 2164A 06/2021 2165A 06/2021 2166A 06/2021 2179A 06/2021 2180A 07/2021 2181A 07/2021 2214A 08/2021 2215A 08/2021 2216A 08/2021
Postal code
19136-1615
Report date
Nov 20, 2019
Product type
Drugs
Recall number
D-0309-2020
Classification
Class II
Recalling firm
Lannett Company, Inc.
Product quantity
683,149 bottles
Termination date
Apr 26, 2021
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Distribution pattern
Nationwide
Recall initiation date
Oct 28, 2019
Initial firm notification
Press Release
Center classification date
Nov 10, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0309-2020, published Nov 20, 2019. 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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