Precision Dose, Inc.
NDC labeler code: 68094
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Morphine sulfateMs Contin, Mitigo, Duramorph · 6 products
- Metformin hydrochlorideGlumetza · 5 products
- DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 3 products
- GabapentinNeurontin, Gralise, Relgaabi · 3 products
- Phentermine hydrochlorideLomaira · 3 products
- AzithromycinZithromax, Azasite · 3 products
- LacosamideVimpat, Motpoly XR · 2 products
- TetrabenazineXenazine · 2 products
- Megestrol acetate2 products
- MidazolamNayzilam · 2 products
- Naltrexone hydrochloride2 products
- FurosemideLasix, Furoscix, Lasix Onyu · 2 products
- CholestyramineQuestran, Prevalite, Cholestyramine Light · 2 products
- CarbamazepineTegretol XR, Equetro, Carbatrol · 2 products
- Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 2 products
- Methazolamide2 products
- Benzonatate2 products
- Sevelamer carbonateRenvela · 1 product
- GuanfacineIntuniv · 1 product
- FosfomycinContepo · 1 product
- OxcarbazepineTrileptal, Oxtellar XR · 1 product
- DiazepamValium, Valtoco · 1 product
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 1 product
- SucralfateCarafate · 1 product
- Phentolamine mesylateOraverse, Ryzumvi · 1 product
- LevetiracetamKeppra, Spritam, Keppra XR · 1 product
- Ondansetron1 product
- ClobazamSympazan, Onfi · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 1 product
- Lithium1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 3, 2025 | ANDA217187 | Fosfomycin FOSFOMYCIN TROMETHAMINE | Precision Dose Inc |
| August 14, 2023 | ANDA218036 | Lithium LITHIUM CITRATE | Rubicon Research |
| February 6, 2023 | ANDA216461 | Lacosamide LACOSAMIDE | Pharmazone |
| October 18, 2022 | ANDA215615 | Methazolamide METHAZOLAMIDE | Tagi |
| October 6, 2022 | ANDA214277 | Carbamazepine CARBAMAZEPINE | Novitium Pharma |
| August 9, 2021 | ANDA204438 | Glycopyrrolate GLYCOPYRROLATE | Ph Health |
| March 9, 2021 | ANDA209597 | Cholestyramine CHOLESTYRAMINE | Pharmobedient |
| November 23, 2020 | ANDA212857 | Dexmedetomidine DEXMEDETOMIDINE HYDROCHLORIDE | Tagi |
| November 12, 2020 | ANDA209599 | Cholestyramine CHOLESTYRAMINE LIGHT | Pharmobedient Cnsltg |
| May 7, 2020 | ANDA212821 | Lidocaine LIDOCAINE HYDROCHLORIDE | Huons |
| December 2, 2019 | ANDA209356 | Sucralfate SUCRALFATE | Amneal |
| April 17, 2019 | ANDA208250 | Azithromycin AZITHROMYCIN | Cspc Ouyi |
| October 25, 2018 | ANDA208249 | Azithromycin AZITHROMYCIN | Cspc Ouyi |
| October 22, 2018 | ANDA210039 | Clobazam CLOBAZAM | Amneal |
| September 24, 2018 | ANDA207566 | Azithromycin AZITHROMYCIN | Cspc Ouyi |
| March 20, 2018 | ANDA209781 | Levetiracetam LEVETIRACETAM | Hainan Poly Pharm |
| November 28, 2017 | ANDA207288 | Sevelamer carbonate SEVELAMER CARBONATE | Amneal Pharms Co |
| October 26, 2017 | ANDA207057 | Gabapentin GABAPENTIN | Cspc Ouyi |
| July 14, 2017 | ANDA207686 | Phentolamine mesylate PHENTOLAMINE MESYLATE | Precision Dose Inc |
| January 31, 2017 | ANDA207682 | Tetrabenazine TETRABENAZINE | Mylan |
| July 11, 2016 | ANDA205096 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Cspc Ouyi |
| July 31, 2015 | ANDA202765 | Benzonatate BENZONATATE | Cspc-Nbp Pharm |
| June 3, 2014 | ANDA203638 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Amneal Pharms |
| September 28, 2012 | ANDA202248 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Elite Labs |
| September 17, 2012 | ANDA202961 | Oxcarbazepine OXCARBAZEPINE | Amneal Pharms |
| January 31, 2011 | ANDA200272 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Elite Labs |
| April 17, 2008 | ANDA078321 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Cspc Ouyi |
| March 17, 2008 | NDA022195 | Morphine sulfate MORPHINE SULFATE | Hikma |
| December 26, 2006 | ANDA076960 | Ondansetron ONDANSETRON HYDROCHLORIDE | Hikma |
| April 30, 2002 | ANDA075873 | Midazolam MIDAZOLAM HYDROCHLORIDE | Hikma |
| July 25, 2001 | ANDA075671 | Megestrol acetate MEGESTROL ACETATE | Strides Pharma Intl |
| May 26, 1999 | ANDA075274 | Naltrexone hydrochloride NALTREXONE HYDROCHLORIDE | Elite Labs |
| November 25, 1998 | ANDA075109 | Guanfacine GUANFACINE HYDROCHLORIDE | Amneal Pharm |
| April 22, 1987 | ANDA070433 | Furosemide FUROSEMIDE | Hikma |
| April 22, 1987 | ANDA070434 | Furosemide FUROSEMIDE | Hikma |
| April 3, 1987 | ANDA070928 | Diazepam DIAZEPAM | Hikma |
| May 22, 1981 | ANDA087393 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Hikma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
July 14, 2026 · Class II · Ongoing · D-0741-2026 · Glycopyrrolate
Failed Impurities/Degradation Specifications
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
-
April 2, 2026 · Class II · Ongoing · D-0532-2026 · Lidocaine
Lack of Assurance of Sterility
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026