SpecGx LLC
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 172 Railroad Avenue P.O. Box P, Hobart, New York (NY) 13788, United States (USA)
- Operations here
- analysisdistributemanufacturepackrelabelrepack
- FDA identifiers
- FEI 1317295 · DUNS 957414238
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2020-03-13
- NAIDrug Quality Assurance2018-04-06
- VAIDrug Quality Assurance2016-01-29
- VAIDrug Quality Assurance2013-08-30
- VAIDrug Quality Assurance2012-04-20
- VAIDrug Quality Assurance2010-01-27
Drugs this plant is listed as making
12 distinct drugs across 51 products name this site in their FDA label.
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateSpecGx LLC
- dextroamphetamine sulfateSpecGx LLC
- Hydrocodone Bitartrate And AcetaminophenSpecGx LLC
- Lisdexamfetamine Dimesylatein shortageSpecGx LLC
- Methadone HydrochlorideSpecGx LLC
- Methylphenidate Hydrochloridein shortageSpecGx LLC
- Morphine Sulfatein shortageSpecGx LLC
- naltrexone hydrochlorideSpecGx LLC
- Oxycodone HydrochlorideSpecGx LLC
- temazepamSpecGx LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.