Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Reported: June 3, 2020 Initiated: May 13, 2020 #D-1274-2020
Product Description
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Reason for Recall
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Details
- Recalling Firm
- West-Ward Columbus Inc
- Units Affected
- 68,376 bottles
- Distribution
- USA Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.. Recalled by West-Ward Columbus Inc. Units affected: 68,376 bottles.
Why was this product recalled? ▼
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 3, 2020. Severity: Moderate. Recall number: D-1274-2020.
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