Why it was recalled
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Product description
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
Lot numbers, UPCs & expiration codes
Lot# 327874, 327876, Exp Dec/2020
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-0863-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 7, 2020
- FDA report date
- Mar 4, 2020
- Quantity
- 29,172 8 Fl Oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0863-2020, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84916
- Address
- 3 Skyline Dr
- Code information
- Lot# 327874, 327876, Exp Dec/2020
- Postal code
- 10532-2174
- Report date
- Mar 4, 2020
- Product type
- Drugs
- Recall number
- D-0863-2020
- Classification
- Class I
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 29,172 8 Fl Oz bottles
- Termination date
- Dec 11, 2023
- Reason for recall
- Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Feb 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2020