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.
Reported: October 3, 2018 Initiated: August 20, 2018 #D-1213-2018
Product Description
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.
Reason for Recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Details
- Recalling Firm
- Hetero Labs Limited Unit V
- Units Affected
- 98,016 bottles
- Distribution
- Nationwide in the USA
- Location
- Jadcherla Mandal, Mahaboob Nagar
Frequently Asked Questions
What product 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.. Recalled by Hetero Labs Limited Unit V. Units affected: 98,016 bottles.
Why was this product recalled? ▼
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2018. Severity: Moderate. Recall number: D-1213-2018.
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