Drug product
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.
D-0347-2019
Product summary
- Event
- Event 81685
- Status
- Terminated
- Classification
- Class I
- Quantity
- 225 syringes
- Official record key
drug-enforcement:D-0347-2019
Official wording
Reason: 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".
Code information: Lot: 11/01/18 8847 80261S, BUD: 03/31/19
Distribution pattern: Heath care facilities in NM, TX, and OH
Derived failure modes
-
Labeling or packaging
Labeling: Label Error