Pharmaceutical Associates, Inc.
NDC labeler code: 0121
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
- NystatinNystop, Klayesta, Nyamyc · 2 products
- Ranitidine2 products
- Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 1 product
- DiazepamValium, Valtoco · 1 product
- LorazepamAtivan, Loreev XR · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| January 7, 2016 | ANDA203621 | Nystatin NYSTATIN | Pharm Assoc |
| June 15, 2010 | ANDA090260 | Lorazepam LORAZEPAM | Pharm Assoc |
| September 21, 2007 | ANDA077405 | Ranitidine RANITIDINE HYDROCHLORIDE | Pharm Assoc |
| April 3, 1987 | ANDA070928 | Diazepam DIAZEPAM | Hikma |
| — | ANDA070979 | Propranolol hydrochloride | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
April 13, 2022 · Class II · Terminated · D-1101-2022 · Diphenhydramine
cGMP deviations: Temperature abuse
Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.
2021
-
July 29, 2021 · Class II · Terminated · D-0723-2021 · Ethosuximide
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
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July 29, 2021 · Class II · Terminated · D-0721-2021 · Nystatin
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, I
2020
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August 4, 2020 · Class II · Terminated · D-1494-2020 · Nystatin
Subpotent drug: Out of specification for assay at the 15-month test interval.
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
-
March 19, 2020 · Class II · Terminated · D-1060-2020 · Nystatin
SubPotent Drug: Low out-of-specification results for assay testing.
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
-
January 14, 2020 · Class II · Terminated · D-0824-2020 · Nystatin
Subpotent: Out of specification for assay at the 12-month time point.
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
2018
-
May 29, 2018 · Class III · Terminated · D-0865-2018 · Nystatin
Resuspension problems: Out of specification for appearance and resuspendability.
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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