Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Reported: February 6, 2019 Initiated: January 9, 2019 #D-0423-2019
Product Description
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Reason for Recall
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 14,400 bottles
- Distribution
- Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket 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/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 14,400 bottles.
Why was this product recalled? ▼
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 6, 2019. Severity: Moderate. Recall number: D-0423-2019.
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