FDA-Drug2020-06-03Class II

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.

West-Ward Columbus Inc
Hazard

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

Sold states
USA Nationwide
Affected count
68,376 bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1274-2020

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