Recall record at a glance
| Official record | D-0721-2021 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | PAI Holdings, LLC. dba Pharmaceutical Associates Inc. |
| Report date | Aug 18, 2021 |
| Recall initiation date | Jul 29, 2021 |
| Quantity | a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case) |
| Location | Greenville, SC, United States |
Official product description
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, Inc. Greenville, SC 29605
Why the product was recalled
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Distribution information
Distributed Nationwide in the USA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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