Why it was recalled
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
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
Lot numbers, UPCs & expiration codes
Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0721-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Aug 18, 2021
- Quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Original FDA data
Every field from FDA enforcement report D-0721-2021, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 88392
- Address
- 1700 Perimeter Rd
- Code information
- Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
- Postal code
- 29605-5252
- Report date
- Aug 18, 2021
- Product type
- Drugs
- Recall number
- D-0721-2021
- Classification
- Class II
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Product quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Termination date
- Dec 2, 2022
- Reason for recall
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2021