PlainRecalls
FDA Drug Moderate Class II 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 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

Reported: January 22, 2020 Initiated: January 10, 2020 #D-0780-2020

Product Description

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

Reason for Recall

Subpotent

Details

Recalling Firm
Letco Medical LLC
Units Affected
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.
Location
Decatur, AL

Frequently Asked Questions

What product was recalled?
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. Recalled by Letco Medical LLC. Units affected: a) 597 jars; b) 411 jars; c) 5 jars; d) 1004 jars: e) 76 jars; f) 1592 jars.
Why was this product recalled?
Subpotent
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2020. Severity: Moderate. Recall number: D-0780-2020.