Reported Jan 22, 2020 · Terminated

Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC…

Letco Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Letco Medical LLC · 1316 Commerce Dr · Decatur, AL · 35601-7539

Is this the product you have?

6 of 6 products

Products covered by this recall
#Product as published
1100 gm NDC 62991-2159-04
21 gm NDC 62991-2159-01
31 kg NDC 62991-2159-06
425 gm NDC 62991-2159-03
5500 gm NDC 62991-2159-05
65 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
Lot codes and dates

6 of 6 products

Products covered by this recall
#Product as published
11804030048 Exp. 06/06/2020; 1712270019, 1802160017 Exp. 08/06/2020; 1804300021, 1806270007, 1808090056, 1904290047 Exp. 04/16/2021; 1810190004, 1812200072, 1901250024 Exp. 08/13/2021; 1902190028, 1907260018 Exp 09/14/2021
21804030049 Exp. 06/06/2020; 1712270020, 1802160018 Exp. 08/06/2020; 1804300022, 1806270008, 1808090057, 1904290048 Exp. 04/16/2021; 1810190005, 1812200073, 1901250025 Exp. 08/13/2021; 1902190029, 1907260019 Exp. 09/14/2021
31802160022 Exp. 08/06/2020; 1810190009, 1812200077 Exp. 08/13/2021; 1907260023 Exp. 09/14/2021
41804030050 Exp 06/06/2020; 1712270021, 1802160019 Exp. 08/06/2020; 1804300023, 1806270009, 1808090058, 1904290049 Exp 04/16/2021; 1810190006, 1812200074, 1901250026 Exp. 08/13/2021; 1902190030, 1907260020 Exp. 09/14/2021
51802160021 Exp. 08/06/2020; 1804300025, 1806270011, 1808090060 Exp. 04/16/2021; 1810190008 Exp. 08/13/2021; 1812200076 Exp. 08/13/2021; 1901250028 Exp. 08/13/2021; 1902190031 Exp. 09/14/2021; 1907260022 Exp. 09/14/2021
61712270022 Exp. 08/06/2020; 1802160020 Exp. 08/06/2020; 1804030051 Exp. 06/06/2020; 1804300024 Exp. 04/16/2021; 1806270010 Exp. 04/16/2021; 1808090059 Exp. 04/16/2021; 1810190007 Exp. 08/13/2021; 1812200075 Exp. 08/13/2021; 1901250027 Exp. 08/13/2021; 1904290050 Exp. 04/16/2021; 1907260021 Exp. 09/14/2021
Amount recalled
a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars

Why it was recalled

Subpotent

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 7, 2021 · Data as of Sep 19, 5:52 PM UTC

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