RecallRadar

FDA Drug recall D-0012-2018

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

On 2017-10-25 the FDA classified a Class II recall of methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10 by Rxq Compounding, citing lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0012-2018
ClassificationClass II
Statusterminated
Initiated2017-09-25
Published2017-10-25
Last updated2026-09-13 11:51 UTC
CompanyRxq Compounding
DistributionFL, LA, MA, OH, PA, TX

Product

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

Reason

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Identifiers

code_infoLot: 04252017@1, exp 5/9/2018

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-0012-2018%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.