Multi-event August 2019 FDA Recall Drug by First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy

This Multi-event Class II drug recall was voluntarily initiated by First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy on August 12, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0250-2020 TERMINATED D-0213-2020 TERMINATED D-0260-2020 TERMINATED D-0215-2020 TERMINATED D-0266-2020 TERMINATED D-0244-2020 TERMINATED D-0226-2020 TERMINATED D-0221-2020 TERMINATED D-0199-2020 TERMINATED D-0297-2020 TERMINATED D-0253-2020 TERMINATED D-0232-2020 TERMINATED D-0237-2020 TERMINATED D-0239-2020 TERMINATED D-0223-2020 TERMINATED D-0236-2020 TERMINATED D-0218-2020 TERMINATED D-0211-2020 TERMINATED D-0286-2020 TERMINATED D-0248-2020 TERMINATED D-0269-2020 TERMINATED D-0214-2020 TERMINATED D-0252-2020 TERMINATED D-0280-2020 TERMINATED D-0267-2020 TERMINATED D-0276-2020 TERMINATED D-0257-2020 TERMINATED D-0268-2020 TERMINATED D-0249-2020 TERMINATED D-0251-2020 TERMINATED D-0204-2020 TERMINATED D-0245-2020 TERMINATED D-0235-2020 TERMINATED D-0278-2020 TERMINATED D-0201-2020 TERMINATED D-0243-2020 TERMINATED D-0225-2020 TERMINATED D-0281-2020 TERMINATED D-0220-2020 TERMINATED D-0287-2020 TERMINATED D-0277-2020 TERMINATED D-0222-2020 TERMINATED D-0208-2020 TERMINATED D-0275-2020 TERMINATED D-0271-2020 TERMINATED D-0254-2020 TERMINATED D-0241-2020 TERMINATED D-0210-2020 TERMINATED D-0227-2020 TERMINATED D-0258-2020 TERMINATED D-0212-2020 TERMINATED D-0230-2020 TERMINATED D-0273-2020 TERMINATED D-0291-2020 TERMINATED D-0205-2020 TERMINATED D-0229-2020 TERMINATED D-0270-2020 TERMINATED D-0290-2020 TERMINATED D-0293-2020 TERMINATED D-0261-2020 TERMINATED D-0247-2020 TERMINATED D-0294-2020 TERMINATED D-0292-2020 TERMINATED D-0289-2020 TERMINATED D-0256-2020 TERMINATED D-0238-2020 TERMINATED D-0288-2020 TERMINATED D-0202-2020 TERMINATED D-0283-2020 TERMINATED D-0207-2020 TERMINATED D-0279-2020 TERMINATED D-0295-2020 TERMINATED D-0284-2020 TERMINATED D-0228-2020 TERMINATED D-0265-2020 TERMINATED D-0216-2020 TERMINATED D-0233-2020 TERMINATED D-0206-2020 TERMINATED D-0285-2020 TERMINATED D-0255-2020 TERMINATED D-0259-2020 TERMINATED D-0246-2020 TERMINATED D-0217-2020 TERMINATED D-0219-2020 TERMINATED D-0234-2020 TERMINATED D-0296-2020 TERMINATED D-0262-2020 TERMINATED D-0282-2020 TERMINATED D-0240-2020 TERMINATED D-0274-2020 TERMINATED D-0272-2020 TERMINATED D-0203-2020 TERMINATED D-0198-2020 TERMINATED D-0224-2020 TERMINATED D-0263-2020 TERMINATED D-0242-2020 TERMINATED D-0231-2020 TERMINATED D-0200-2020 TERMINATED D-0209-2020 TERMINATED D-0264-2020 TERMINATED

Recall Number: D-0250-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
11x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S03062019JL@11, Exp 9/6/19; S04282019DH@05, Exp 10/28/19; S06182019DT@04, Exp 12/18/19; S06242019DH@11, Exp 12/24/19; " S07232019DH@15, Exp 1/23/20

Recall Number: D-0213-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S05092019DH@06, Exp 8/9/19

Recall Number: D-0260-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
7x10 ml dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :S05082019ST@05, Exp 8/8/19; S05212019DT@08, Exp 8/21/19; S05312019DT@10, Exp 8/31/19; S06272019DT@03, Exp 9/27/19; S07222019DH@06, Exp 10/22/19

Recall Number: D-0215-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10 glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06262019DT@08, Exp 9/26/19

Recall Number: D-0266-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
11x 5ml and 10ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : a) S06112019DH@10, Exp 8/11/19; b) S06112019DH@10, Exp 8/11/19, S06142019DH@03, Exp 8/14/19, S06252019DH@14, Exp 8/25/19, S07222019DH@02, Exp 9/22/19

Recall Number: D-0244-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S07092019DT@08, Exp 8/9/19

Recall Number: D-0226-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
81 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# :a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19; S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19

Recall Number: D-0221-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1 5ml bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S07292019DH@08, Exp 9/29/19

Recall Number: D-0199-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
81 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : a) S04112019DT@07,Exp 8/11/19; S05012019DT@01, 9/1/19; S05142019DT@13, 9/14/19; S05282019DT@07, 9/28/19; S06042019DT@05, 10/4/19; S06182019DH@15, 10/18/19; S07102019DT@13, 12/10/19; S07172019DT@09, 12/17/19 b) S04172019DT@01, 8/17/19; c) S07172019DT@09, 12/17/19

Recall Number: D-0297-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
34x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S07162019DH@07, EXP. 9/16/19 b) S06242019DH@01, EXP 8/24/19; S07102019DT@15, EXP. 9/20/19; S07252019DH@03, EXP. 9/25/19; S07312019DH@13, EXP. 9/31/19 c) S07102019DT@03, EXP. 9/10/19 d) S07262019DH@01, EXP. 9/26/19; S07232019DH@07, EXP. 9/23/19 e) S06262019DH@05, EXP. 8/26/19; S07132019DT@06, EXP. 9/13/19 f) S06162019DH@12, EXP. 8/16/19 g) S06252019DT@06, EXP. 8/25/19; S07032019DT@04, EXP. 9/3/19; S07102019DT@02, EXP. 9/10/19; h) S07172019dt@13, EXP. 9/17/19 i) S07032019DT@01, EXP. 9/3/19 j) S06092019DH@07, EXP. 8/9/19; S06112019DH@03, EXP. 8/11/19; S06122019DT@01, EXP. 8/12/19 k) S07022019DT@05, EXP. 9/2/19; S07132019DT@04, EXP. 9/13/19 l) S07022019DT@01, EXP. 9/2/19; S07302019DH@06, EXP. 9/30/19 m) S06252019DT@07, EXP. 8/25/19; n) S07022019DT@04, EXP. 9/2/19

Recall Number: D-0253-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05302019DT@03Exp 08/30/2019

Recall Number: D-0232-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x30 ml vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S05162019DH@10, Exp 8/16/19

Recall Number: D-0237-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07162019DH@15, Exp 8/16/19

Recall Number: D-0239-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x10 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S05082019DT@01, Exp 9/8/19; S05222019DH@03, Exp 9/22/19

Recall Number: D-0223-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1, 3 ml prefilled syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07262019DH@02, Exp 8/26/19

Recall Number: D-0236-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x30 ML vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07292019DH@06, Exp 8/12/19

Recall Number: D-0218-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
11 5ml and 10ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S05092019DH@08, Exp 8/9/19; S06112019DH@14, Exp 9/11/19; S07222019DH@04, Exp 10/22/19

Recall Number: D-0211-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
37x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S03072019DH@08; Exp 9/7/19; S02142019DH@08, Exp 8/14/19; S03072019DH@07, Exp 9/7/19; 03072019DH@08, 9/7/19; S03042019DH@07, Exp 9/4/19, S04172019DT@02, Exp 10/17/19; S05232019DT@10, Exp 11/23/19; S06242019DH@10, Exp 12/24/19; S07172019DT@07, Exp 1/17/20; S07242019DH@09, Exp 1/24/20

Recall Number: D-0286-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
129x 5ml, 10ml, 13ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S02252019DH@07, Exp 8/25/19; S03202019DT@02, EXP, 8/25/19; S03212019DT@02, EXP, 9/21/19; S04232019DT@06, EXP, 10/23/19; S05232019DT@06, EXP, 11/23/19; S05152019DH@12, EXP, 11/15/19; S05242019DT@03, EXP, 11/24/19; 05152019DH@12, EXP, 11/15/19; S06262019DT@02, EXP, 12/26/19; S07032019DT@12, EXP, 1/3/20; S07132019DT@03, EXP, 1/13/20; S07162019DT@01, EXP, 1/16/20; S07262019DH@06, EXP, 1/26/20; S05152019DH@12, EXP, 11/15/19

Recall Number: D-0248-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x5ml Glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06302019DH@03, Exp 8/30/19

Recall Number: D-0269-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
16 5ml and 10ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S06242019DH@07; 9/24/19 b) S07222019DH@09, Exp 10/22/19; S05292019DT@06, Exp 8/29/19; S06032019DT@08, Exp 9/3/19; S06242019DH@07; 9/24/19

Recall Number: D-0214-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
10x50m ml and 1x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19

Recall Number: D-0252-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
13x5 and 10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S02132019DT@02, Exp 8/13/19; b) S04092019DT@05, Exp 10/9/19; S06122019DH@35, Exp 12/12/19; S06172019DH@04, Exp 12/17/19

Recall Number: D-0280-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05292019dt@01, Exp 8/29/19

Recall Number: D-0267-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x30 Ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S05232019DT@01, Exp 8/23/19

Recall Number: D-0276-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
7x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S03302019DT@02, Exp 09/30/2019, S05062019DH@12, Exp 11/06/2019, S06162019DH@13, Exp 12/16/2019, S07132019DT@05, Exp 01/13/2020

Recall Number: D-0257-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
16x5 and 10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/19; S06122019DT@06, Exp 10/12/19; S06192019DT@10, Exp 10/19/19; s07092019dt@16, Exp 11/9/19; S07242019DH@10, Exp 11/24/19

Recall Number: D-0268-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S07162019DT@04, Exp 10/16/19; b) S07162019DT@04 Exp 10/16/19

Recall Number: D-0249-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07102019DT@12, Exp 8/10/19

Recall Number: D-0251-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07232019DH@12, Exp 11/23/19; S07292019DH@05, Exp 11/29/19

Recall Number: D-0204-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
5x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S05132019DH@02, Exp 8/13/19; S05142019DT@05, Exp 8/14/19; S07032019DT@10, Exp 10/3/19; S07182019DH@01, Exp 10/18/19

Recall Number: D-0245-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x30 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S0726209DH@07, Exp 10/26/19

Recall Number: D-0235-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x1 ml syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06192019DT@02, Exp 8/19/19; S06262019DT@11, Exp 8/26/19; S07312019DH@06, Exp 9/31/19

Recall Number: D-0278-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S07092019DT@19, Exp 08/09/2019, S07292019DH@09, Exp 08/29/2019

Recall Number: D-0201-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
6x10 ml, 1x50 ml dropper bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : a) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19

Recall Number: D-0243-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06242019DH@08, Exp 9/24/19; S07242019DH@08, Exp 10/24/19; S07312019DH@03, Exp 10/31/19

Recall Number: D-0225-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
5x30 ML vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S05142019DT@09, Exp 8/14/19; S07162019DT@14, Exp 10/16/19; S07232019DH@06, Exp 10/23/19

Recall Number: D-0281-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x10ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S03152019JL@03, Exp 9/15/19

Recall Number: D-0220-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
5x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S06162019DH@09, Exp 9/16/19; S06032019DT@01, Exp 9/30/19

Recall Number: D-0287-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07162019DH@08, Exp 10/16/19; S05092019DH@05, Exp 8/9/19

Recall Number: D-0277-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x30 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05242019DT@10, Exp 08/31/2019

Recall Number: D-0222-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2 1L- bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy

Batch or Lot Expiration Information

Lot# : S07092019DT@18, Exp 8/23/19; S07312019DH@08, Exp 10/14/19

Recall Number: D-0208-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07312019DH@15, Exp 8/31/19

Recall Number: D-0275-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
108x 10 and 30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020

Recall Number: D-0271-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
135x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S05162019DH@12, Exp 8/16/19; S05282019DT@06, Exp 8/28/19; S05302019DT@05, Exp 8/30/19; S06182019DT@03, Exp 9/18/19; S07102019dt@05, Exp 10/10/19; S07162019DT@08, Exp 10/16/19; S07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/19; S06242019DH@01, Exp 9/24/19; S07032019DT@10, EXP 10/03/2019, S07102019DT@05, Exp 10/10/2019, 07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/2019, S07292019DH@15, Exp 10/29/19

Recall Number: D-0254-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06142019DH@01, Exp 8/14/19

Recall Number: D-0241-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
24x30 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S02142019DH@01, Exp 8/14/19; S03112019DT@04, Exp 09/11/2019, S03192019DT@04, Exp 9/19/19; S04162019DT@15, Exp 10/16/19; S07172019DT@10, Exp 1/17/20; S07232019DH@04, Exp 1/23/20

Recall Number: D-0210-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
8x30 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07292019DH@13, Exp 8/29/19

Recall Number: D-0227-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x5 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07232019DH@13, Exp 8/23/19; S07312019DH@14, Exp 8/31/19

Recall Number: D-0258-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
22x10 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# S06112019DH@13, Exp 9/11/19; S06162019DH@03, Exp 9/16/19; S06182019DH@08, Exp 9/18/19; S06242019DH@12, Exp 9/24/19; S07162019DT@10, Exp 10/16/19

Recall Number: D-0212-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
5x50 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S06092019DH@09, Exp 9/9/19; S06252019DT@11, 9/25/19; S07092019DT@07, Exp 10/9/19; S07092019DT@13, Exp 10/9/19

Recall Number: D-0230-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30 glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# :S07242019DH@05, Exp 10/24/19

Recall Number: D-0273-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
28x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19

Recall Number: D-0291-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# :S04222019DH@03 Exp 10/22/2019, S06162019DH@05, Exp 12/16/2019

Recall Number: D-0205-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
4x1000 plastic containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19

Recall Number: D-0229-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S05082019DT@02, Exp 8/8/19; S05112019DH@17, Exp 8/11/19

Recall Number: D-0270-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,

Batch or Lot Expiration Information

Lot# :S07092019DT@20, Exp 10/9/19; S07242019DH@08, Exp 10/24/19

Recall Number: D-0290-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x 10ml and 13 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# :a) S06182019DH@03, Exp 9/18/19; S07292019DH@04, Exp 10/29/19; b) S07092019DT@12, Exp 10/9/19

Recall Number: D-0293-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
46 x30 ML glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :S04102019DT@09, Exp 8/10/19; S05012019DT@03, Exp 9/1/19; S05162019DH@21, Exp 9/16/19; S05152019DH@21,Exp 9/16/19; S06162019DH@14, Exp 10/16/19; S06262019DT@03, Exp 10/26/19; S06262019DT@10, Exp 10/26/19; S07252019DH@11, Exp 11/25/19

Recall Number: D-0261-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
10 50 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# :S07232019DH@14 Exp 8/23/19; S07162019DT@06 Exp 8/16/19; S07172019DT@04 Exp 8/17/19

Recall Number: D-0247-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
38x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S03072019DH@10, Exp 9/7/19; S04162019DT@18, Exp 10/16/19; S05162019DH@09, Exp 11/16/19; S05232019DT@11, Exp 11/23/19; s06182019dh@31, Exp 12/18/19; S06242019DH@14, Exp 12/24/19; S07172019DT@08, Exp 1/17/20; S07232019DH@16, Exp 1/23/20; S06242019DH@14, Exp 12/24/19

Recall Number: D-0294-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05162019DT@04, Exp 8/16/19

Recall Number: D-0292-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
10x10 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# :S07132019DT@01, Exp 10/13/19;S07312019DH@05, Exp 10/31/19 S06122019DT@09, Exp 9/12/19

Recall Number: D-0289-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06242019DH@06, Exp 9/24/2019

Recall Number: D-0256-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S07292019DH@16, Exp 10/29/19

Recall Number: D-0238-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06192019DT@04, Exp 9/19/19

Recall Number: D-0288-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
4x 10ml and 13 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : a) S05212019DH@13, Exp 8/21/19; S06302019DH@07, Exp 9/30/19; S07252019DH@10, Exp 10/25/19; b) S05092019DH@05, Exp 8/9/19

Recall Number: D-0202-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x10 ml dropper bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S05232019DH@03, Exp 8/23/19; S07172019DT@03,Exp 10/17/19

Recall Number: D-0283-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07162019DT@12, Exp 1/16/20

Recall Number: D-0207-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
18x10 ml and 1x5 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19

Recall Number: D-0279-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b) S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19

Recall Number: D-0295-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5 ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :S06092019DH@04, Exp 8/9/19

Recall Number: D-0284-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06162019DH@02, Exp 9/16/19

Recall Number: D-0228-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S06092019DH@03, Exp 9/9/19; S06162019DH@17, Exp 9/16/19

Recall Number: D-0265-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
8x10 ML vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S06272019DT@07, Exp 8/27/19; S07262019DH@04, Exp 9/26/19; S07302019DH@04, Exp 9/30/19

Recall Number: D-0216-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05212019DT@06 Exp, 5/21/19; S06262019DT@08, Exp 6/26/19

Recall Number: D-0233-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x2ML syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06242019DH@04, Exp 9/24/19

Recall Number: D-0206-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10 glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07092019DT@14, Exp 8/9/19

Recall Number: D-0285-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
559 x 5, 10, 13 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@03 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19

Recall Number: D-0255-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S07232019DH@08 Exp 10/23/19

Recall Number: D-0259-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x50 ml plastic container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07162019DT@05 exp: 8/14/2019

Recall Number: D-0246-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10ml droptainer

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S05232019DT@13, Exp 8/23/19

Recall Number: D-0217-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x50ml, 6x100ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19

Recall Number: D-0219-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x5ml, 1x10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S07232019DH@10, Exp 10/23/19; S08012019DH@03, Exp 11/1/19

Recall Number: D-0234-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
13x50 ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06112019DH@16, Exp 9/11/19; S06182019DT@02, Exp 9/18/19; S06182019DH@33, Exp 9/18/19; S06252019DT@08, Exp 9/25/19; S08022019DH@01, Exp 11/2/19

Recall Number: D-0296-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
3x5ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# :S06092019DH@07, Exp 8/9/19; S06112019DH@03, Exp 8/11/19;S06122019DH@01, Exp 8/12/19

Recall Number: D-0262-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5ml, 7x10ml, 3x11ml, glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# :S05092019DH@07, Exp 8/9/19; S05082019DT@11, Exp 8/8/19; S07032019DT@13, Exp 10/3/19; S07092019DT@09, Exp 10/9/19; S07292019DH@03, Exp 10/29/19

Recall Number: D-0282-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
91 x 5, 10, 13 ML glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S02192019DH@14, Exp 8/19/19; S02282019DH@06, Exp 8/28/19; S03142019DT@04, Exp 9/14/19; S03252019DH@03, Exp 9/25/19; S04102019DT@05, Exp 10/10/19; S05012019DT@03, Exp 11/1/19; S05022019DT@11, Exp 11/2/19; s05012019dt@09, Exp 11/2/19; S5212019DH@14, Exp 11/21/19; S06032019DT@07, Exp 12/3/19; S06122019DT@08, Exp 12/12/19; S07162019DT@13, Exp 1/16/20; S07262019DH@05, Exp 1/26/20; S05212019DH@14, Exp 8/21/19

Recall Number: D-0240-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
60x 10 and 30 ML glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX

Batch or Lot Expiration Information

Lot# : a) S05162019DH@10, EXP 08/16/2019,S05242019DT@07, EXP 8/24/19, S07182019DT@14 EXP 10/18/19, b) S05162019DH@18, Exp 8/16/19;S07102019DT@04, EXP 10/10/19,S07262019DH@10 EXP 10/26/19, S07292019DH@10 EXP 10/29/19

Recall Number: D-0274-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19

Recall Number: D-0272-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# :S05082019DT@16, Exp 8/8/19, S06052019DT@07, Exp 9/5/19

Recall Number: D-0203-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10 ml dropper bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# : S05232019DH@04, Exp 8/23/19

Recall Number: D-0198-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2 x 30 mL vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S06272019DT@08, BUD: 9/27/2019

Recall Number: D-0224-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x12 ML and 79x30 ML vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : a) S06252019DH@12, Exp 9/25/19; S07162019DT@02, Exp 10/16/19; b) S05162019DH@19, Exp 8/16/19; S05072019DT@08, Exp 8/7/19; S05082019DT@07, Exp 8/8/19; S05282019DT@08, Exp 8/28/19; S05312019DT@05, Exp 8/31/19; S06182019DH@11, Exp 9/18/19; S06242019DH@09, Exp 9/24/19; S07102019DT@06, Exp 10/10/19; S07162019DT@03, Exp 10/16/19; S07222019DH@10, Exp 10/22/19

Recall Number: D-0263-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2 5ml and 10 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

Batch or Lot Expiration Information

Lot# S06062019DH@03, Exp 9/6/19; S06182019DH@01, Exp 9/18/19

Recall Number: D-0242-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10ml glass vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : S07022019DT@02, Exp 10/2/19

Recall Number: D-0231-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x5 ml vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx

Batch or Lot Expiration Information

Lot# : S06192019DT@09, Exp 9/19/19

Recall Number: D-0200-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
2x 10 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX

Batch or Lot Expiration Information

Lot# : S07222019DH@09, Exp 8/22/19

Recall Number: D-0209-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
5x10 ml and 5x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# : a) S05312019DT@03, Exp 8/31/19;S06032019DT@05, Exp 9/3/19 S06122019DT@07, Exp 9/12/19; b) S05312019DT@07, Exp 8/31/19; S06122019DT@07, Exp 9/12/19;S06252019DH@11, Exp 9/25/19; S07172019DT@01, Exp 10/25/19

Recall Number: D-0264-2020

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-12-2019
Reported
11-13-2019
Quantity
1x10, 1x30 ml glass vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83669
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.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-13-2023
Product Description About Product Description
Full technical description of the product.
S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx.

Batch or Lot Expiration Information

Lot# S05162019DH@17, Exp 8/26/19; S07262019DH@08, Exp 10/26/19