RecallRadar

FDA Drug recall D-1032-2019

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella o…

On 2019-03-27 the FDA classified a Class II recall of Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella o… by Advanced Pharma, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1032-2019
ClassificationClass II
Statusterminated
Initiated2019-03-13
Published2019-03-27
Last updated2026-09-13 11:52 UTC
CompanyAdvanced Pharma
DistributionUS

Product

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot: 11/01/18 8847 80261S Exp. 3/31/2019

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-1032-2019%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.