Recalls / Class II
Class IID-0117-2018
Product
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
- Affected lot / code info
- Lot: 5/31/17 0202 5-81862S, BUD 7/30/17
Why it was recalled
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 50 syringes
- Distribution pattern
- Nationwide in the USA to hospitals and medical facilities.
Timeline
- Recall initiated
- 2017-06-09
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0117-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.