Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Reported: June 8, 2016 Initiated: March 11, 2016 #D-0955-2016
Product Description
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Reason for Recall
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 741.171 kg
- Distribution
- Nationwide and Puerto Rico
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 741.171 kg.
Why was this product recalled? ▼
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 8, 2016. Severity: Low. Recall number: D-0955-2016.
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