Class I
Terminated
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.
- Company
- Advanced Pharma Inc.
- Recall Initiated
- November 29, 2018
- Posted
- January 2, 2019
- Recall Number
- D-0347-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 225 syringes
- Firm Location
- Houston, TX, United States
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
Heath care facilities in NM, TX, and OH
Lot / Code Info
Lot: 11/01/18 8847 80261S, BUD: 03/31/19
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