Drug recall: Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness…
Class II FDA enforcement event 72241. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II, in the words of FDA
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
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma started this drug recall on 3 Sep 2015. The firm address in the FDA record is in Peoria, IL. FDA put the recall in Class II. FDA event 72241 has 39 product records. The first FDA enforcement report date is 25 Nov 2015. The record gives the status Terminated, with the termination date 29 Dec 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma, Peoria, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
39 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-298-2016 | Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 dropper bottles | Class II | Terminated | 25 Nov 2015 |
| D-299-2016 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 4 vials | Class II | Terminated | 25 Nov 2015 |
| D-300-2016 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 35 vials | Class II | Terminated | 25 Nov 2015 |
| D-301-2016 | BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 5 vials | Class II | Terminated | 25 Nov 2015 |
| D-302-2016 | Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 7 dropper bottles | Class II | Terminated | 25 Nov 2015 |
| D-303-2016 | Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 ointment tubes | Class II | Terminated | 25 Nov 2015 |
| D-304-2016 | DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | a) 720 vials; b) 4 vials | Class II | Terminated | 25 Nov 2015 |
| D-305-2016 | Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 dropper bottle | Class II | Terminated | 25 Nov 2015 |
| D-306-2016 | HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 49 vials | Class II | Terminated | 25 Nov 2015 |
| D-307-2016 | HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-308-2016 | HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-309-2016 | HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-310-2016 | HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-311-2016 | HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 21 vials and 80 prefilled syringes | Class II | Terminated | 25 Nov 2015 |
| D-312-2016 | LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 76 vials | Class II | Terminated | 25 Nov 2015 |
| D-313-2016 | LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-314-2016 | Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 10 prefilled syringes | Class II | Terminated | 25 Nov 2015 |
| D-315-2016 | Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-316-2016 | Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 28 prefilled syringes | Class II | Terminated | 25 Nov 2015 |
| D-317-2016 | Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 8 prefilled syringes | Class II | Terminated | 25 Nov 2015 |
| D-318-2016 | Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 30 prefilled syringes | Class II | Terminated | 25 Nov 2015 |
| D-319-2016 | MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-320-2016 | Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 50 vials | Class II | Terminated | 25 Nov 2015 |
| D-321-2016 | Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-322-2016 | Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-323-2016 | QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-324-2016 | Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 7 vials | Class II | Terminated | 25 Nov 2015 |
| D-325-2016 | Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 64 vials | Class II | Terminated | 25 Nov 2015 |
| D-326-2016 | sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-327-2016 | Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 5 vials | Class II | Terminated | 25 Nov 2015 |
| D-328-2016 | Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 261 vials | Class II | Terminated | 25 Nov 2015 |
| D-329-2016 | Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-330-2016 | Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 20 vials | Class II | Terminated | 25 Nov 2015 |
| D-331-2016 | Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-332-2016 | TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 6 vials | Class II | Terminated | 25 Nov 2015 |
| D-333-2016 | TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 5 vials | Class II | Terminated | 25 Nov 2015 |
| D-334-2016 | TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 2 vials | Class II | Terminated | 25 Nov 2015 |
| D-335-2016 | TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
| D-336-2016 | TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | 1 vial | Class II | Terminated | 25 Nov 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class II
- 52%
- Product records in this event
- 39
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-298-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 72241. https://recallregister.com/fda/ii/72241/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 72241?
- The event has 39 product records. The first record gives this quantity:
2 dropper bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 52% of the 292 drug events that started in 2015 are in Class II.