Recall Record

Albuquerque, NM, United States

Calvin Scott & Company, Inc. recalls

3 recalls recorded since 2018, most recently on 15 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)1

Terminated Class I, Class III Drugs

Recall started
15 January 2021
Terminated
8 November 2022
Reason
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Distribution
1 physician in Alpharetta, GA
Initiated
Voluntary: Firm initiated
Recall numbers
D-1124-2022, D-1123-2022

Terminated Class II Drugs

Recall started
16 September 2020
Terminated
22 April 2024
Reason
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Distribution
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
Initiated
Voluntary: Firm initiated
Recall numbers
D-0009-2021, D-0011-2021, D-0010-2021

Terminated Class II Drugs

Recall started
27 July 2020
Terminated
11 April 2024
Reason
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall numbers
D-1525-2020, D-1514-2020, D-1528-2020, D-1522-2020, D-1521-2020, D-1518-2020, D-1532-2020, D-1515-2020, D-1516-2020, D-1524-2020, D-1519-2020, D-1527-2020 and 7 more

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.