FDA-Drug2018-10-03Class II
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Hetero Labs Limited Unit V
Hazard
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Sold states
Nationwide in the USA
Affected count
98,016 bottles
Manufactured in
Unit V (SEZ Unit I in APIIC SEZ), Surv. No. 439-441, 458, Polepally Vill., Jadcherla Mandal, Mahaboob Nagar, India
Products
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1213-2018Don't want to check this manually?
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