Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadc…
- Recall date
- August 20, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1213-2018
- FDA classification
- Class II
- Brand / firm
- Hetero Labs Limited Unit V
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever Hetero Labs Limited Unit V has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Hetero Labs Limited Unit V