SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Reported: May 20, 2015 Initiated: March 17, 2015 #D-0995-2015
Product Description
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 27,648 bottles (16 fl. oz. each)
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701. Recalled by Akorn, Inc.. Units affected: 27,648 bottles (16 fl. oz. each).
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-0995-2015.
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