Recalls / Class I
Class ID-0114-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Affected lot / code info
- Lot: 4/10/17 1441 257-86367S, BUD 6/9/17; 4/17/17 0950 86367S, BUD¿6/16/2017; 4/20/17 1505 257-86367S, BUD 6/19/2017; 4/24/17 0115 15-86367S, BUD ¿6/23/2017; 4/26/17 0301 387-86367S, BUD 6/25/2017
Why it was recalled
Subpotent Drug: found to be below the specification for labeled assay.
Recalling firm
- Firm
- Advanced Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9265 Kirby Dr, Houston, Texas 77054-2520
Distribution
- Quantity
- 320 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-0114-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.