Multi-event September 2020 FDA Recall Drug by Preferred Pharmaceuticals, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on September 2, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Repackaged tablets sold to three physicians located in CA and GA. and the recall is currently terminated.

Reported Recall Events

D-1621-2020 TERMINATED D-1622-2020 TERMINATED D-1623-2020 TERMINATED D-1624-2020 TERMINATED

Recall Number: D-1621-2020

Reason for Recall
CGMP Deviations
Initiated
09-02-2020
Reported
09-30-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86394
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Repackaged tablets sold to three physicians located in CA and GA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-25-2024
Product Description About Product Description
Full technical description of the product.
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01

Batch or Lot Expiration Information

Lot# : L2717G, Exp. Date: 12/31/2020
Lot# : B2618A, Exp. Date: 12/21/2020
Lot# : C1419P, Exp. Date: 2/28/2021

Recall Number: D-1622-2020

Reason for Recall
CGMP Deviations
Initiated
09-02-2020
Reported
09-30-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86394
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Repackaged tablets sold to three physicians located in CA and GA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-25-2024
Product Description About Product Description
Full technical description of the product.
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09

Batch or Lot Expiration Information

Lot# : B2618E, Exp. Date: 2/28/2021

Recall Number: D-1623-2020

Reason for Recall
CGMP Deviations
Initiated
09-02-2020
Reported
09-30-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86394
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Repackaged tablets sold to three physicians located in CA and GA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-25-2024
Product Description About Product Description
Full technical description of the product.
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# a)
Lot# : A0220Q, Exp. Date: 10/31/2020; b)
Lot# : K15171, Exp. Date: 10/31/2020

Recall Number: D-1624-2020

Reason for Recall
CGMP Deviations
Initiated
09-02-2020
Reported
09-30-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86394
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Repackaged tablets sold to three physicians located in CA and GA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-25-2024
Product Description About Product Description
Full technical description of the product.
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09

Batch or Lot Expiration Information

Lot# a)
Lot# : A0220R, Exp. Date: 2/28/2021