Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Reported: July 29, 2020 Initiated: July 2, 2020 #D-1406-2020
Product Description
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Reason for Recall
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 35,928 bottles
- Distribution
- U.S.A. Nationwide
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 35,928 bottles.
Why was this product recalled? ▼
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 29, 2020. Severity: Moderate. Recall number: D-1406-2020.
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