Multi-event August 2020 FDA Recall Drug by Rlc Labs Inc.
This Multi-event Class II drug recall was voluntarily initiated by Rlc Labs Inc. on August 25, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-1598-2020 D-1596-2020 D-1612-2020 D-1609-2020 D-1614-2020 D-1607-2020 D-1601-2020 D-1606-2020 D-1602-2020 D-1605-2020 D-1599-2020 D-1619-2020 D-1610-2020 D-1616-2020 D-1600-2020 D-1604-2020 D-1617-2020 D-1603-2020 D-1608-2020 D-1615-2020 D-1618-2020 D-1597-2020 D-1613-2020 D-1611-2020
Recall Number: D-1598-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299-1; and e) 1000-count bottles, NDC 64727-3299-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1596-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC 64727-3300-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1612-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1609-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1614-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
Batch or Lot Expiration Information
Lot# : 119142, Exp. Date 01/2022
Recall Number: D-1607-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1601-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64727-3307-1; and e) 1,000-count bottles, NDC 64727-3307-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1606-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1602-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1; and e) 1,000-count bottles, NDC 64727-3308-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1605-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1; and e) 1,000-count bottles, NDC 64727-3312-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1599-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 64727-3303-1; e) 1,000-count bottles, NDC 64727-3303-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between10/2020-07/2023
Recall Number: D-1619-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1
Batch or Lot Expiration Information
Lot# : 109286, Exp. Date 10/2022
Recall Number: D-1610-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1616-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# : 109242, Exp. Date 11/2022
Recall Number: D-1600-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3305-4; b) 60-count bottles, NDC 64727-3305-5; c) 90-count bottles, NDC 64727-3305-6; d) 100-count bottles, NDC 64727-3305-1; and e) 1,000-count bottles, NDC 64727-3305-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1604-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1617-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1
Batch or Lot Expiration Information
Lot# : 109032, Exp. Date 10/2022
Recall Number: D-1603-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1608-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1615-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# : 099186, Exp. Date 11/2022
Recall Number: D-1618-2020
Subpotent Drug: FDA analysis found product to be subpotent
08-25-2020
09-23-2020
N/A
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
Batch or Lot Expiration Information
Lot# : 109264, Exp. Date 10/2022
Recall Number: D-1597-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-3302-1; and e) 1,000-count bottles, NDC 64727-3302-2; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034.
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1613-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
Recall Number: D-1611-2020
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
08-25-2020
09-23-2020
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.
RLC Labs 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the United States
11-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Batch or Lot Expiration Information
Lot# All lots with expiry between 10/2020-07/2023
