PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 27, 2019 Initiated: March 13, 2019 #D-1032-2019

Product Description

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 for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Advanced Pharma Inc.
Units Affected
1850 syringes
Distribution
Nationwide
Location
Houston, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Advanced Pharma Inc.. Units affected: 1850 syringes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1032-2019.