The Recall Desk
ModerateFDA (Drugs)·D-0118-2018·Announced 2017-12-27

Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is related to product stability rather than a high-risk pathogen or structural defect.

Plain-English summary

Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin (1 mg/5 mL) in 5% Dextrose Injection, USP. The product is packaged in sterile single-dose syringes and is available by prescription only. The recall affects specific lots with expiration dates ranging from June 2017 to July 2017.

The recall was initiated because stability data does not support the use of the container system for the stated expiry dates. This means the product may not remain stable or effective until the printed expiration date.

The affected product was distributed nationwide to hospitals and medical facilities. Healthcare facilities should stop using the recalled lots and contact Advanced Pharma Inc. for further instructions. Consumers should not use this product and should contact their healthcare provider if they have questions.

The recalled product

Product
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
Manufacturer
Advanced Pharma Inc.
Category
Drug — Injection
Hazard
Affected units
680

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 (20)

  • Lot: 4/26/17 0730 20-86367S
  • BUD 6/25/17
  • 4/24/17 0106 241-86367S
  • BUD 6/23/17
  • 5/1/17 1500 45-86367S
  • BUD 6/30/17
  • 5/9/17 1103 241-86367S
  • BUD 7/8/17
  • 5/9/17 1104 257-86367S
  • 5/12/17 0839 15-86367S
  • BUD 7/11/17
  • 5/19/17 0109 15-86367S
  • BUD 7/18/17
  • 5/22/17 0828 387-86367S
  • BUD 7/21/17
  • 5/23/17 0721 257-86367S
  • BUD 7/22/17
  • 5/24/17 0200 241-86367S
  • BUD 7/23/17
  • 5/24/17 0203 20-86367S

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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