Multi-event September 2016 FDA Recall Drug by Wells Pharmacy Network Llc

This Multi-event Class II drug recall was voluntarily initiated by Wells Pharmacy Network Llc on September 21, 2016 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-0344-2017 TERMINATED D-0389-2017 TERMINATED D-0364-2017 TERMINATED D-0331-2017 TERMINATED D-0327-2017 TERMINATED D-0415-2017 TERMINATED D-0330-2017 TERMINATED D-0350-2017 TERMINATED D-0371-2017 TERMINATED D-0332-2017 TERMINATED D-0351-2017 TERMINATED D-0373-2017 TERMINATED D-0421-2017 TERMINATED D-0368-2017 TERMINATED D-0341-2017 TERMINATED D-0401-2017 TERMINATED D-0355-2017 TERMINATED D-0408-2017 TERMINATED D-0412-2017 TERMINATED D-0392-2017 TERMINATED D-0398-2017 TERMINATED D-0410-2017 TERMINATED D-0336-2017 TERMINATED D-0385-2017 TERMINATED D-0375-2017 TERMINATED D-0419-2017 TERMINATED D-0366-2017 TERMINATED D-0346-2017 TERMINATED D-0405-2017 TERMINATED D-0349-2017 TERMINATED D-0418-2017 TERMINATED D-0381-2017 TERMINATED D-0391-2017 TERMINATED D-0329-2017 TERMINATED D-0383-2017 TERMINATED D-0395-2017 TERMINATED D-0347-2017 TERMINATED D-0380-2017 TERMINATED D-0394-2017 TERMINATED D-0361-2017 TERMINATED D-0376-2017 TERMINATED D-0337-2017 TERMINATED D-0335-2017 TERMINATED D-0357-2017 TERMINATED D-0388-2017 TERMINATED D-0378-2017 TERMINATED D-0399-2017 TERMINATED D-0348-2017 TERMINATED D-0333-2017 TERMINATED D-0365-2017 TERMINATED D-0377-2017 TERMINATED D-0403-2017 TERMINATED D-0340-2017 TERMINATED D-0382-2017 TERMINATED D-0334-2017 TERMINATED D-0409-2017 TERMINATED D-0414-2017 TERMINATED D-0367-2017 TERMINATED D-0384-2017 TERMINATED D-0343-2017 TERMINATED D-0339-2017 TERMINATED D-0420-2017 TERMINATED D-0390-2017 TERMINATED D-0396-2017 TERMINATED D-0345-2017 TERMINATED D-0387-2017 TERMINATED D-0359-2017 TERMINATED D-0386-2017 TERMINATED D-0417-2017 TERMINATED D-0362-2017 TERMINATED D-0423-2017 TERMINATED D-0358-2017 TERMINATED D-0369-2017 TERMINATED D-0404-2017 TERMINATED D-0400-2017 TERMINATED D-0338-2017 TERMINATED D-0422-2017 TERMINATED D-0360-2017 TERMINATED D-0416-2017 TERMINATED D-0406-2017 TERMINATED D-0407-2017 TERMINATED D-0352-2017 TERMINATED D-0411-2017 TERMINATED D-0379-2017 TERMINATED D-0393-2017 TERMINATED D-0356-2017 TERMINATED D-0397-2017 TERMINATED D-0413-2017 TERMINATED D-0374-2017 TERMINATED D-0402-2017 TERMINATED D-0328-2017 TERMINATED D-0363-2017 TERMINATED D-0353-2017 TERMINATED D-0370-2017 TERMINATED D-0372-2017 TERMINATED D-0354-2017 TERMINATED D-0342-2017 TERMINATED

Recall Number: D-0344-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
44 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07222016@2, 08172016@1

Recall Number: D-0389-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
3,089 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@180, 06132016@155, 06232016@147, 07062016@156, 07272016@68, 08232016@24, 09062016@74. Known vial lot code: 04212016@110, 052412016@76, 05312016@40, 06102016@52, 07152016@56, 08192016@20, 08102016@56.

Recall Number: D-0364-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
189 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@3, 04252016@4, 05172016@4, 06162016@6, 07212016@8.

Recall Number: D-0331-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,968 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes: 03292016@3, 04202016@4, 05162016@6, 06102016@9, 07202016@44, 08032016@38

Recall Number: D-0327-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 694 vials b) 389 vials c) 695 vials d) 5193 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.

Recall Number: D-0415-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 9 vials and b) 78 vials, c) 210 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07222016@15 b) Known lot code: 04122016@17, 05182016@16, 09082016@28 c) Known lot code: 04072016@13, 05192016@22, 06132016@36, 08032016@35.

Recall Number: D-0330-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 1,312 vials and b) 3,354 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03292016@12, 0422016@10, 04222016@10, 05052016@33, 05122016@11, 05132016@19, 05242016@2, 06212016@17, 07262016@36, 09072016@21, 09142015@17 b) Known lot code: 03242016@9, 04112016@10, 04212016@19, 05042016@20, 05132016@21, 05202016@71, 06152016@7, 07122016@21, 08032016@17, 09092016@35.

Recall Number: D-0350-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,638 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04052016@14, 05162016@126, 06092016@173, 06202016@137, 08042016@97, 09132016@117. Known vial lot code: 03242016@31, 04262016@25, 06032016@44, 06202016@137, 07252016@56, 09092016@17.

Recall Number: D-0371-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
511 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: a) 04192016@7, 05132016@7, 07052016@19, 08102016@9 and b) 04262016@4, 05132016@9, 05192016@9, 05252016@25, 08122016@1.

Recall Number: D-0332-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
308 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03292016@5, 04122016@76, 04202016@5, 05182016@2, 06102016@2, 06282016@71, 09092016@1

Recall Number: D-0351-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
908 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04212016@42, 06092016@164, 08122016@96. Known vial lot code: 04132016@96, 05242016@1, 08082016@50.

Recall Number: D-0373-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07132016@5.

Recall Number: D-0421-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
335 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04202016@1, 05052016@6, 06062016@1, 08012016@34.

Recall Number: D-0368-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
633 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04222016@4, 05112016@24, 05162016@14, 06082016@8, 06222016@42, 07272016@8

Recall Number: D-0341-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
30 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06032016@7, 09092016@5

Recall Number: D-0401-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
146 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04142016@5, 04292016@5, 05022016@6, 07062016@7.

Recall Number: D-0355-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
438 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04132016@69, 04272016@9, 05142016@13, 06162016@129, 07052016@12, 07292016@2.

Recall Number: D-0408-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 238 vials and b) 607 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 05042016@19, 06142016@28, 07262016@34, 09072016@22 b) Known lot code: 04112016@8, 05232016@2, 06212016@21, 07012016@22, 09082016@31.

Recall Number: D-0412-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
42 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code:03292016@79, 05262016@15, 07082016@9, 09082016@25.

Recall Number: D-0392-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
176 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04062016@170, 05272016@67, 09132016@98. Known vial lot code: 03302016@12, 050412016@84, 08222016@27.

Recall Number: D-0398-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
67 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04062016@4, 05232016@120, 06142016@9, 09122016@9.

Recall Number: D-0410-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07192016@8.

Recall Number: D-0336-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
10 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04052016@16, 04072016@26, 04142016@65, 05172016@105, 06062016@137, 06152016@28, 06232016@61, 07272016@56, 08192016@108, 09062016@127 Known vial lot code: 03252016@6, 03312016@1, 04042016@30, 05052016@134, 05092016@57, 06072016@32, 06172016@120, 07222016@26, 07222016@26, 08122016@3, 08252016@3.

Recall Number: D-0385-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
114 vials and b) 1,017 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@8, 06272016@22, 09082016@29 b) Known lot code: 04142016@16, 04272016@8, 06102016@13, 07062016@29, 08052016@1.

Recall Number: D-0375-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
648 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@8, 04152016@5, 05032016@15, 05262016@24, 06142016@1, 07202016@55.

Recall Number: D-0419-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
550 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04122016@4, 05042016@3, 06012016@8, 06212016@5, 07252016@22.

Recall Number: D-0366-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
265 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04152016@3, 05192016@1, 06132016@23, 07132016@10, 08112016@22, 09062016@32.

Recall Number: D-0346-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
18 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06072016@44, 07292016@92, 08092016@80, 09132016@33. Known vial lot code: 04042016@30, 07222016@26, 04042016@30, 08252016@3

Recall Number: D-0405-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
433 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@4, 04012016@9, 04042016@9, 04132016@14, 05062016@3, 06022016@7, 06152016@22, 06292016@25, 07282016@12.

Recall Number: D-0349-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
2,339 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code:04212016@49, 05262016@154, 06092016@181, 08082016@118, 08252016@89. Known vial lot code: 04142016@34, 05202016@55, 06032016@42, 08012016@41, 08192016@47.

Recall Number: D-0418-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 2 vials,, b) 9 vials and 6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@27 b) Knonw lot code: 06202016@162 c) Known lot code: 07262016@49.

Recall Number: D-0381-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
219 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04072016@29, 08122016@103. Known vial lot code: 03302016@13, 03252016@16, 08082016@58, 08082016@67.

Recall Number: D-0391-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
158 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@215, 09062016@92. Known vial lot code: 04252016@158, 082612016@45.

Recall Number: D-0329-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,250 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes: 03282016@3, 04132016@1, 05262016@3, 06242016@97, 07282016@1

Recall Number: D-0383-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 1,165 vials b) 2,217 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11.

Recall Number: D-0395-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
2,264 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04152016@149, 05182016@176, 06172016@142, 07272016@83, 08232016@32, 09122016@138. Known vial lot code: 04072016@91, 04262016@27, 05272016@41, 07192016@29, 08192016@18, 09062016@44.

Recall Number: D-0347-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1753 kits (number of vials per kit vary)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04212016@46, 05232016@215, 05232016@216, 07052016@89, 08042016@103, 09132016@116. Known vial lot code: 04132016@91, 05162016@136, 06242016@96, 07282016@51, 09092016@20

Recall Number: D-0380-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
2,336 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@201, 04202016@33, 05182016@46, 05232016@227, 06072016@55, 06092016@88, 06142016@60, 07012016@112, 07132016@142, 07292016@121, 07292016@129. Known vial lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94.

Recall Number: D-0394-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
3 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@100. Known vial lot code: 05042016@94.

Recall Number: D-0361-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
148 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07252016@46, 08112016@19.

Recall Number: D-0376-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
159

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@5, 04192016@8, 05242016@15, 06222016@28, 08102016@2.

Recall Number: D-0337-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 24 vials, b) 91 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32

Recall Number: D-0335-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
325 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04152016@2, 05052016@2, 05192016@7, 07142016@28, 09122016@23

Recall Number: D-0357-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
22 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05272016@18.

Recall Number: D-0388-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
629 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04212016@55, 06222016@106. Known vial lot code: 04142016@31, 06012016@50.

Recall Number: D-0378-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
41 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05022016@160

Recall Number: D-0399-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
266 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04012016@2, 05052016@4, 06022016@13, 06102016@35, 07052016@6.

Recall Number: D-0348-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
5277 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33

Recall Number: D-0333-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@13, 06302016@95, 08082016@58.

Recall Number: D-0365-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 499 vials b) 1214 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04062016@5, 05172016@1, 06162016@2, 07202016@47, 08222016@6 b) Known lot code: 04052016@1, 05032016@1, 05182016@1, 05262016@32, 06162016@13, 06232016@74, 07012016@18, 08092016@6, 09062016@33

Recall Number: D-0377-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
122 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04142016@107, 05242016@128

Recall Number: D-0403-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
203 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03242016@4, 04122016@1, 05102016@10, 06092016@4, 07062016@12, 08152016@3.

Recall Number: D-0340-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
351 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05122016@3, 07072016@15, 08302016@65

Recall Number: D-0382-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
526 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@16, 04282016@3, 05202016@6, 06132016@4, 07052016@1, 07272016@7.

Recall Number: D-0334-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
714 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@5, 04202016@2, 05172016@5, 06082016@44, 06102016@6, 08042016@14

Recall Number: D-0409-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 6 vials, b) 19 vials and c) 41 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04042016@22 b) Known lot code: 07192016@3 c) Known lot code: 04112016@13.

Recall Number: D-0414-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 2 vials b) 3 vials and c) 7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@25 b) Known lot code 06202016@157 c) Known lot code: 05042016@16.

Recall Number: D-0367-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
7 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04292016@93, 07282016@26, 09082016@37. Known vial lot code: 04052016@1, 05262016@32, 08092016@6.

Recall Number: D-0384-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 191 vials and b) 794 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04222016@8, 06142016@42, 08152016@17 b) Known lot code: 03312016@8, 05182016@15, 08092016@18

Recall Number: D-0343-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 80 vials, b) 23 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04012016@7, 04252016@17, 05262016@13, 06142016@39, 08052016@13 b) Known lot code: 05242016@11, 09072016@18

Recall Number: D-0339-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
37 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 05092016@3, 07192016@8

Recall Number: D-0420-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
237 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@23, 05132016@3, 06062016@7, 06272016@17.

Recall Number: D-0390-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,319 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04072016@19, 05272016@55, 06102016@62, 09062016@75. Known vial lot code: 03302016@11, 050412016@98, 05172016@10, 08252016@18.

Recall Number: D-0396-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
106 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05272016@73. Known vial lot code: 05042016@91.

Recall Number: D-0345-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
46 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06062016@118. Vial lot code 05272016@47

Recall Number: D-0387-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
330 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@51, 05262016@146, 06212016@76, 08052016@74. Known vial lot code: 04252016@163, 05042016@87, 07192016@31.

Recall Number: D-0359-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
137 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07012016@10, 08032016@42, 08182016@11.

Recall Number: D-0386-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
568 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05182016@173, 07052016@148, 09062016@114. Known vial lot code: 04252016@165, 06102016@56, 08262016@42.

Recall Number: D-0417-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 1 vial and b) 12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 07192016@7 b) Known lot code: 04122016@18.

Recall Number: D-0362-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
131 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 08232016@42. Known vial lot code: 08172016@45.

Recall Number: D-0423-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04182016@33, 06022016@5

Recall Number: D-0358-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
147 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06232016@14, 07212016@2, 08012016@35, 08192016@11.

Recall Number: D-0369-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
106 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06292016@10, 08092016@19, 08232016@5.

Recall Number: D-0404-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
469 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04042016@2, 04282016@1, 05262016@2, 06272016@8, 08162016@12.

Recall Number: D-0400-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a ) 303 vials and b) 413 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04212016@5, 05102016@123, 05232016@21, 07132016@18 b) Known lot code: 04142016@7, 05042016@6, 05252016@2, 06222016@30, 07132016@25, 07282016@5.

Recall Number: D-0338-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
21 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03312016@9

Recall Number: D-0422-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04082016@6, 06012016@6, 06142016@148

Recall Number: D-0360-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
199 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 06292016@9, 07252016@39, 08102016@24.

Recall Number: D-0416-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07192016@26.

Recall Number: D-0406-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
18 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07212016@15.

Recall Number: D-0407-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 257 vials and b) 460 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04072016@10, 05102016@18, 06232016@12, 08182016@26 b) Known lot code: 04122016@19, 05042016@18, 06142016@43, 07122016@40, 07262016@47.

Recall Number: D-0352-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
724 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05042016@162, 06062016@122, 08192016@110. Known vial lot code: 04252016@168, 05252016@117, 08152016@40.

Recall Number: D-0411-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04112016@6.

Recall Number: D-0379-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
315 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05122016@84, 07012016@107. Known vial lot code: 04212016@149, 06082016@7.

Recall Number: D-0393-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,255 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05162016@37, 06172016@161, 06242016@135, 08112016@121. Known vial lot code: 04202016@8, 05252016@33, 05312016@47, 08042016@39.

Recall Number: D-0356-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
203 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 06082016@133. Known vial lot code: 05202016@4.

Recall Number: D-0397-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1,232 kits (number of vials per kit vary by prescription)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04192016@24, 05172016@229, 06032016@136, 06222016@121, 06222016@148, 09132016@102. Known vial lot code: 03242016@27, 04202016@7, 05162016@141, 06032016@47, 05312016@53, 08222016@54.

Recall Number: D-0413-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 56 vials and b) 48 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code:05182016@17, 07222016@16, 08182016@27 b) Known lot code:03312016@7, 05192016@23, 08032016@34.

Recall Number: D-0374-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
984 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04052016@5, 04082016@3, 04182016@37, 05032016@2, 05182016@3, 05232016@22, 06072016@18, 06282016@45, 07252016@52, 08262016@8.

Recall Number: D-0402-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
a) 798 vials and b) 3,191 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03202016@10, 04072016@85, 04182016@4, 05062016@5, 05262016@1, 06132016@1, 08112016@4 b) Known lot code: 03282016@6, 04122016@2, 04182016@33, 05092016@6, 05192016@3, 06022016@5, 06072016@3, 06172016@3, 06292016@2, 07112016@5, 07262016@29, 07292016@12.

Recall Number: D-0328-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
157 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known Lot No. 03282016@22, 05162016@5, 07252016@16. Known lot codes: 03282016@22, 05162016@5, 07262016@16

Recall Number: D-0363-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
433 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04132016@32, 05062016@4, 05312016@5, 06132016@93, 06282016@36, 08172016@5.

Recall Number: D-0353-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 07082016@25.

Recall Number: D-0370-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
933 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 04082016@4, 05102016@1, 05172016@6, 06032016@3, 06092016@17, 06212016@42, 07012016@32, 07272016@16, 08172016@13, 4252016@21.

Recall Number: D-0372-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
1716 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03302016@9, 04072016@15, 05022016@14, 05052016@5, 05162016@16, 06012016@11, 06092016@30, 06152016@15, 06212016@2, 07152016@8, 08042016@21.

Recall Number: D-0354-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
16 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 08082016@45.

Recall Number: D-0342-2017

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-21-2016
Reported
01-11-2017
Quantity
180 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75289
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.
Wells Pharmacy Network LLC
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-02-2021
Product Description About Product Description
Full technical description of the product.
B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL

Batch or Lot Expiration Information

Lot# All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot code: 03252016@2, 04292016@11, 06122016@9, 07212016@11