Recalls / Class I
Class ID-0347-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- Lot: 11/01/18 8847 80261S, BUD: 03/31/19
Why it was recalled
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".
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 225 syringes
- Distribution pattern
- Heath care facilities in NM, TX, and OH
Timeline
- Recall initiated
- 2018-11-29
- FDA classified
- 2019-01-07
- Posted by FDA
- 2019-01-02
- Terminated
- 2019-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0347-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.