Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Reported: January 16, 2019 Initiated: January 2, 2019 #D-0376-2019
Product Description
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Reason for Recall
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 287,784 bottles
- Distribution
- Nationwide within the United States
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 287,784 bottles.
Why was this product recalled? ▼
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 16, 2019. Severity: Moderate. Recall number: D-0376-2019.
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