RecallRadar

FDA Drug recall D-1027-2017

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

On 2017-08-02 the FDA classified a Class II recall of PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40 by Sca Pharmaceuticals, citing lack of Assurance of Sterility; product has the potential to leak.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1027-2017
ClassificationClass II
Statusterminated
Initiated2017-07-14
Published2017-08-02
Last updated2026-09-13 11:51 UTC
CompanySca Pharmaceuticals
DistributionUS

Product

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

Reason

Lack of Assurance of Sterility; product has the potential to leak.

Identifiers

code_infoLots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017

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-1027-2017%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.