Reported Apr 5, 2017 · Terminated
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc.,…
Hetero USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hetero USA Inc · 1035 Centennial Ave · Piscataway, NJ · 08854-4124
Is this the product you have?
- Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only
- Manufactured forCamber Pharmaceuticals, Inc., Piscataway, NJ 08854
- ByHETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
- Lot codes and dates
Lot # MON16001BExp 01/18
- Amount recalled
- 65,664 bottles
Where it was sold
- Nationwide
Why it was recalled
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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