FDAClass IIJanuary 22, 2020

Estriol USP Micronized a) 100 gm recall: Subpotent

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 62991-2159-03; e) 500 gm NDC…

Why was Estriol USP Micronized a) 100 gm recalled?

Subpotent

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: a) 1804030048 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; b) 1804030049 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; c) 1802160022 Exp. 08/06/2020; 1810190009, 1812200077 Exp. 08/13/2021; 1907260023 Exp. 09/14/2021; d) 1804030050 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; e) 1802160021 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; f) 1712270022 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

Product
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 62991-2159-03; e) 500 gm NDC…
Recalling firm
Letco Medical LLC
Quantity
a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars
Distribution
United States, Australia, Canada, Israel, Philippines, Taiwan.
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls