Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Product description
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
Lot numbers, UPCs & expiration codes
Lot #: 327B16002, Exp 12/17
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-1049-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 30, 2016
- FDA report date
- Jun 29, 2016
- Quantity
- 60 bottles (5 cases)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prinston Pharmaceutical Inc
Original FDA data
Every field from FDA enforcement report D-1049-2016, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74423
- Address
- 2002 Eastpark Blvd
- Code information
- Lot #: 327B16002, Exp 12/17
- Postal code
- 08512-3514
- Report date
- Jun 29, 2016
- Product type
- Drugs
- Recall number
- D-1049-2016
- Classification
- Class III
- Recalling firm
- Prinston Pharmaceutical Inc
- Product quantity
- 60 bottles (5 cases)
- Termination date
- Jun 9, 2017
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 30, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2016