RecallRadar

FDA Drug recall D-491-2013

Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration

On 2013-06-05 the FDA classified a Class II recall of Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration by Nora Apothecary And Alternative Therapies, citing lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-491-2013
ClassificationClass II
Statusterminated
Initiated2013-04-22
Published2013-06-05
Last updated2026-09-13 11:51 UTC
CompanyNora Apothecary And Alternative Therapies
DistributionUS

Product

Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration

Reason

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Identifiers

code_infoAll products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-491-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.