FDA Drug Recalls

Recalls / Class II

Class IID-1530-2020

Product

Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10

Affected lot / code info
Lot #:19207; Exp. Date: 9/21; 19251, Exp. Date: 9/20; 19284, Exp. Date:10/20; 19316, Exp. Date: 12/20

Why it was recalled

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Recalling firm

Firm
Calvin Scott & Company, Inc.
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
209 Eubank Blvd Ne, N/A, Albuquerque, New Mexico 87123-2745

Distribution

Quantity
N/A
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2020-07-27
FDA classified
2020-08-20
Posted by FDA
2020-08-26
Terminated
2024-04-11
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1530-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls