RecallRadar

FDA Drug recall D-0963-2018

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe

On 2018-07-25 the FDA classified a Class II recall of ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0963-2018
ClassificationClass II
Statusterminated
Initiated2018-06-12
Published2018-07-25
Last updated2026-09-13 11:52 UTC
CompanyAvella Of Deer Valley Store 38
DistributionUS

Product

ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67

Reason

Lack of Assurance of Sterility: Potential leakage of bags.

Identifiers

code_info
Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S,…Lot #: 3/5/18 6702 80567S, 3/5/18 2119 80567S, BUD 7/3/2018; 4/30/18 3701 80567S, BUD 8/28/2018; 5/10/18 3333 80567S, 5/10/18 2222 80567S, 5/10/18 1111 80567S, BUD 9/7/2018. .

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0963-2018%22

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