FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Sacrosidase (Sucraid) Oral Solution
Status: Currently in Shortage
»Date first posted: 07/09/2015
»Therapeutic Categories: Gastroenterology; Inborn Errors

QOL Medical, LLC (Revised 08/07/2018)

Company Contact Information:

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
8,500 I.U./mL 118 mL per bottle, 2 bottles/box (NDC 67871-111-04) Limited availability from lot D1015 (approx. 989 boxes) Shortage related to unavailable approved active pharmaceutical ingredient (API) from a supplier due to requirements related to complying with good manufacturing practices. There is a shortage of Sucraid because the process that has been used for making Sucraid does not meet FDA’s pharmaceutical standards, and the conversion to the required updated process has been delayed. Limited releases by QOL to date under informed consent due to ongoing shortage of approved product: Lot A1147 (expiration dates: 10/2015 and 05/2016), Lot A1150 (expiration date: 06/2017), Lot B1210 (expiration date: 07/2018*), Lot B1102 (expiration date: 06/2018), and Lot B1213 (expiration date: 07/2018), Lot C0502 (expiration date: 12/2018), Lot C0902 (expiration date: 04/2019), Lot C1201 (expiration date: 06/2019), Lot C1102 (expiration date: 05/2019), Lot D0401 (expiration date: 10/2019), Lot D0402 (expiration date: 11/2019), Lot D0403 (expiration date: 10/2019), Lot D0607 (expiration date: 06/2020), Lot D0901 (expiration date: 03/2020), Lot D0904 (expiration date: 03/2020), Lot D0912 (expiration date: 04/2020), Lot D1015 (expiration date: 06/2020).

Sucraid Lot D1015 Physician and Patient Informed Consent Forms to Obtain Product

Link to FDA Related Information for Sacrosidase Oral Solution
*Important Update: Expiration Date for Sucraid Lot B1210
Requirements related to complying with good manufacturing practices.

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