The Recall Desk
HighFDA (Drugs)·D-0632-2023·Announced 2023-05-24

PHENYLephrine HCl Injection Recalled for Lack of Sterility Assurance

Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of an injectable pharmaceutical product with a sterility assurance defect. While no illnesses or confirmed contamination has been reported, injectable products pose inherent risk if contaminated. The precautionary nature of the recall and lack of reported harm justify a score of 3 rather than 4.

Plain-English summary

Apollo Care, LLC is recalling PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL) in single-use syringes for intravenous use due to lack of assurance of sterility. A total of 2,265 syringes are affected, with lot numbers AC-016606 (expiration 05/06/2023), AC-016636 (expiration 07/09/2023), and AC-016643 (expiration 07/31/2023).

The product was distributed in Missouri only. Because this is an injectable medication administered intravenously, contamination could pose a risk to patients who received the affected product.

Healthcare facilities and pharmacies that received this product should stop use and quarantine affected lots immediately. Contact Apollo Care, LLC for instructions on return and replacement. Healthcare providers should consult medical and patient records to identify patients who may have received the recalled product and monitor them for any signs of infection or adverse reactions.

The recalled product

Product
PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable / Intravenous
Hazard
  • sterility-assurance
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: AC-016606
  • Exp. Date 05/06/2023
  • AC-016636
  • Exp. Date 07/09/2023
  • AC-016643
  • Exp. Date 07/31/2023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category