Why it was recalled
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Product description
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
Lot numbers, UPCs & expiration codes
Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17
Where it was sold
Nationwide in USA and Puerto Rico
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-0165-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 28, 2016
- FDA report date
- Dec 7, 2016
- Quantity
- 2,882,661 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nationwide Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0165-2017, exactly as published.
Show all FDA fields
- City
- Iselin
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75655
- Address
- 33 Wood Ave S Ste 600
- Code information
- Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17
- Postal code
- 08830-2717
- Report date
- Dec 7, 2016
- Product type
- Drugs
- Recall number
- D-0165-2017
- Classification
- Class II
- Recalling firm
- Nationwide Laboratories, LLC
- Product quantity
- 2,882,661 tablets
- Termination date
- May 17, 2018
- Reason for recall
- CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
- Distribution pattern
- Nationwide in USA and Puerto Rico
- Recall initiation date
- Oct 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2016