Why it was recalled
Labeling: Label Mixup; potentially mislabeled
Product description
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
Lot numbers, UPCs & expiration codes
a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot # 71346A; Exp. 12/19, Lot # 70989A; Exp. 02/18
Where it was sold
Nationwide
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-1114-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 20, 2017
- FDA report date
- Aug 30, 2017
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- C. O. Truxton
Original FDA data
Every field from FDA enforcement report D-1114-2017, exactly as published.
Show all FDA fields
- City
- Bellmawr
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77082
- Address
- 136 Harding Ave
- Code information
- a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot # 71346A; Exp. 12/19, Lot # 70989A; Exp. 02/18
- Postal code
- 08031-2412
- Report date
- Aug 30, 2017
- Product type
- Drugs
- Recall number
- D-1114-2017
- Classification
- Class II
- Recalling firm
- C. O. Truxton
- Product quantity
- unknown
- Termination date
- Sep 11, 2018
- Reason for recall
- Labeling: Label Mixup; potentially mislabeled
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 20, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 22, 2017