Recalls / Class II
Class IID-0780-2020
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 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601
- Affected lot / code info
- 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
Why it was recalled
Subpotent
Recalling firm
- Firm
- Letco Medical LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1316 Commerce Dr, Decatur, Alabama 35601-7539
Distribution
- Quantity
- a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars
- Distribution pattern
- United States, Australia, Canada, Israel, Philippines, Taiwan.
Timeline
- Recall initiated
- 2020-01-10
- FDA classified
- 2020-01-15
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0780-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.