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.
Reported: December 7, 2016 Initiated: October 28, 2016 #D-0165-2017
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.
Reason for Recall
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Details
- Recalling Firm
- Nationwide Laboratories, LLC
- Units Affected
- 2,882,661 tablets
- Distribution
- Nationwide in USA and Puerto Rico
- Location
- Iselin, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nationwide Laboratories, LLC. Units affected: 2,882,661 tablets.
Why was this product recalled? ▼
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0165-2017.
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