The Recall Desk
ModerateFDA (Drugs)·D-0119-2018·Announced 2017-12-27

Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

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

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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The issue is related to stability data rather than a confirmed contamination or defect causing immediate harm.

Plain-English summary

Advanced Pharma Inc. is recalling NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP) sterile single-dose syringes. The recall involves 550 syringes distributed nationwide to hospitals and medical facilities. The specific lots affected include those with expiration dates ranging from June 19, 2017, to July 17, 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.

Hospitals and medical facilities should stop using the affected lots and contact Advanced Pharma Inc. for further instructions. Consumers are not directly affected as this is a prescription-only product distributed to medical facilities.

The recalled product

Product
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
Manufacturer
Advanced Pharma Inc.
Category
Drug — Injection
Hazard
Affected units
550

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 (14)

  • Lot: 4/20/17 0307 265-86361S
  • BUD 6/19/17
  • 4/26/17 0732 265-86361S
  • BUD 6/25/17
  • 4/28/17 0215 265-86361S
  • BUD 6/27/17
  • 5/2/17 0310 248-86361S
  • BUD 7/1/17
  • 5/4/17 1422 248-86361S
  • BUD 7/3/17
  • 5/12/17 0841 248-86361S
  • BUD 7/11/17
  • 5/18/17 0206 250-86361S
  • BUD 7/17/17

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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Same hazard · stability issue

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