Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Reported: January 23, 2019 Initiated: January 7, 2019 #D-0380-2019
Product Description
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Reason for Recall
CGMP Deviation; manufacturing batch record could not be located
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 7,215 bottles
- Distribution
- Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 7,215 bottles.
Why was this product recalled? ▼
CGMP Deviation; manufacturing batch record could not be located
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2019. Severity: Moderate. Recall number: D-0380-2019.
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