The Recall Desk
SevereFDA (Drugs)·D-1020-2019·Announced 2019-03-27

Advanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns

Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), particularly when the agency's classification is explicitly Class II.

Plain-English summary

Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution. The product is distributed in 5mL sterile single-use syringes with NDC 42852-830-67. The recall is being conducted because of a lack of assurance of sterility.

The affected lots were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between March 2019 and June 2019. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected syringes and contact Advanced Pharma Inc. for further instructions. Consumers should check their medication for the specific NDC and lot numbers listed in the official recall notice to determine if they are affected.

The recalled product

Product
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Manufacturer
Advanced Pharma Inc.
Category
Drug — Injectable Solution
Hazard
Affected units
16,075

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 (11)

  • Lots: 01/18/19 3261 83067S Exp. 6/17/2019
  • 10/18/18 0212 83067S Exp. 3/17/2019
  • 10/23/18 7704 83067S Exp. 3/22/2019
  • 11/02/18 5909 83067S Exp. 4/1/2019
  • 10/31/18 8995 83067S Exp. 3/30/2019
  • 10/22/18 2570 83067S Exp. 3/21/2019
  • 10/18/18 6471 83067S Exp. 3/17/2019
  • 11/05/18 5527 83067S Exp. 4/4/2019
  • 11/05/18 0985 83067S Exp. 4/4/2019
  • 10/22/18 9234 83067S Exp. 3/21/2019
  • 10/30/18 6678 83067S Exp. 3/29/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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