Home / Recalls / Advanced Pharma Inc. / D-0347-2019

D-0347-2019 Class I Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

FDA drug recall D-0347-2019 was initiated by Advanced Pharma Inc. on Nov 29, 2018 and is designated Class I. Reason for recall: Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL". The recall status is terminated (terminated May 2, 2019). Affected quantity: 225 syringes.

Recall Details

Product Type: Drugs
Report Date: Jan 2, 2019
Initiation Date: Nov 29, 2018
Termination Date: May 2, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 225 syringes

Product Description

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

Reason for Recall

Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".

Distribution Pattern

Heath care facilities in NM, TX, and OH

Code Information

Lot: 11/01/18 8847 80261S, BUD: 03/31/19

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0347-2019
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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