Multi-event September 2020 FDA Recall Drug by Calvin Scott & Company, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Calvin Scott & Company, Inc. on September 16, 2020 for the product Drug. The FDA reported the reason for recall as cmgp deviations. The product was distributed in Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0011-2021
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
09-16-2020
10-14-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Calvin Scott & Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
04-22-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Batch or Lot Expiration Information
Lot# : CS19309, CS20098, Exp 12/21
Recall Number: D-0010-2021
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
09-16-2020
10-14-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Calvin Scott & Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
04-22-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
Batch or Lot Expiration Information
Lot# : CS19192, CS19226, CS19263, Exp 10/20; CS19300, Exp 7/21; CS19338, Exp 8/21; CS20034, Exp 10/21; CS20077, Exp 1/22, CS20165, CS20241, Exp 4/22
Recall Number: D-0009-2021
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
09-16-2020
10-14-2020
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Calvin Scott & Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
04-22-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
Batch or Lot Expiration Information
Lot# : CS19311, CS19337, Exp 12/20; CS20018B, CS20019, CS20037, CS20075, CS20076, CS20112, CS20169, Exp 8/21; CS20168, Exp 12/21; CS20199, Exp 5/22; CS20243, Exp 7/22
