Why it was recalled
SubPotent Drug: Low out-of-specification results for assay testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: BE85, Exp. 11/2020
Where it was sold
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-1060-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 7416 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Original FDA data
Every field from FDA enforcement report D-1060-2020, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 85302
- Address
- 1700 Perimeter Rd
- Code information
- Lot: BE85, Exp. 11/2020
- Postal code
- 29605-5252
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1060-2020
- Classification
- Class II
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Product quantity
- 7416 bottles
- Termination date
- Sep 22, 2021
- Reason for recall
- SubPotent Drug: Low out-of-specification results for assay testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2020