Drug recall: Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
Class II FDA enforcement event 81002. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility
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
Pharm D Solutions, LLC started this drug recall on 10 Sep 2018. The firm address in the FDA record is in Houston, TX. FDA put the recall in Class II. FDA event 81002 has 79 product records. The first FDA enforcement report date is 7 Nov 2018. The record gives the status Terminated, with the termination date 5 Feb 2021.
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
Pharm D Solutions, LLC, Houston, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
79 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0136-2019 | Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10 | 486 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0137-2019 | Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20 | 7150 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0138-2019 | Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50 | 10000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0139-2019 | Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30 | 6000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0140-2019 | Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10 | 285 vials | Class II | Terminated | 7 Nov 2018 |
| D-0141-2019 | Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05 | 130 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0142-2019 | Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03 | 148 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0143-2019 | Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03 | 115 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0144-2019 | Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas | 29 vials | Class II | Terminated | 7 Nov 2018 |
| D-0145-2019 | Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02 | 567 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0146-2019 | Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10 | 25 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0147-2019 | Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12 | 29 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0148-2019 | Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30 | 6850 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0149-2019 | Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas | 57 bottles; 2300 milliliters | Class III | Terminated | 7 Nov 2018 |
| D-0150-2019 | Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30 | 2000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0151-2019 | Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60 | 70 bottles | Class II | Terminated | 7 Nov 2018 |
| D-0152-2019 | Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03 | 945 syringes | Class II | Terminated | 7 Nov 2018 |
| D-0153-2019 | Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59 | 1095 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0154-2019 | Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30 | 4000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0155-2019 | Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30 | 180 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0156-2019 | HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10 | 2219 vials | Class II | Terminated | 7 Nov 2018 |
| D-0157-2019 | HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | 3 vials | Class II | Terminated | 7 Nov 2018 |
| D-0158-2019 | HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06 | 10 vials | Class II | Terminated | 7 Nov 2018 |
| D-0159-2019 | HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10 | 1171 vials | Class II | Terminated | 7 Nov 2018 |
| D-0160-2019 | HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12 | 881 vials | Class II | Terminated | 7 Nov 2018 |
| D-0161-2019 | HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 | 765 vials | Class II | Terminated | 7 Nov 2018 |
| D-0162-2019 | HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01 | 2737 vials | Class II | Terminated | 7 Nov 2018 |
| D-0163-2019 | HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | 114 vials | Class II | Terminated | 7 Nov 2018 |
| D-0164-2019 | HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06 | 442 vials | Class II | Terminated | 7 Nov 2018 |
| D-0165-2019 | Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10 | 3000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0166-2019 | Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas | 896 vials; 64000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0167-2019 | Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10 | 4 vials | Class II | Terminated | 7 Nov 2018 |
| D-0168-2019 | Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas | 24500 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0169-2019 | Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50 | 264 vials | Class II | Terminated | 7 Nov 2018 |
| D-0170-2019 | Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10 | 1139 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0171-2019 | Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10 | 630 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0172-2019 | Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20 | 1900 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0173-2019 | Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05 | 193 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0174-2019 | Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05 | 154 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0175-2019 | Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05 | 189 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0176-2019 | Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30 | 600 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0177-2019 | QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05 | 25 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0178-2019 | Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50 | 517 syringes | Class II | Terminated | 7 Nov 2018 |
| D-0179-2019 | Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18 | 179 vials | Class II | Terminated | 7 Nov 2018 |
| D-0180-2019 | Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10 | 409 vials | Class II | Terminated | 7 Nov 2018 |
| D-0181-2019 | Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10 | 124 vials | Class II | Terminated | 7 Nov 2018 |
| D-0182-2019 | Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10 | 330 vials | Class II | Terminated | 7 Nov 2018 |
| D-0183-2019 | Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10 | 250 vials | Class II | Terminated | 7 Nov 2018 |
| D-0184-2019 | Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10 | 420 vials | Class II | Terminated | 7 Nov 2018 |
| D-0185-2019 | Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10 | 108 vials | Class II | Terminated | 7 Nov 2018 |
| D-0186-2019 | Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-30 | 5000 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0187-2019 | 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10 | 12 bags | Class II | Terminated | 7 Nov 2018 |
| D-0188-2019 | Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50 | 10 bags | Class II | Terminated | 7 Nov 2018 |
| D-0189-2019 | Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10 | 3523 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0190-2019 | Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas | 553 vials | Class II | Terminated | 7 Nov 2018 |
| D-0191-2019 | Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas | 609 vials | Class II | Terminated | 7 Nov 2018 |
| D-0192-2019 | Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03 | 67 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0193-2019 | Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03 | 20 milliliters | Class II | Terminated | 7 Nov 2018 |
| D-0194-2019 | Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05 | 9 vials | Class II | Terminated | 7 Nov 2018 |
| D-0195-2019 | Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05 | 20 milliliters | Class II | Terminated | 7 Nov 2018 |
The table shows 60 of 79 product records. The FDA enforcement report lists all the records.
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 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 79Median of the firm: 18
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 May 2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6 | Drug | Class II | 18 |
| 19 Nov 2018 | Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 | Drug | Class II | 1 |
| 12 Oct 2016 | Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop | Drug | Class III | 2 |
Official channels
- FDA enforcement report D-0136-2019The 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 81002. https://recallregister.com/fda/ii/81002/. 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 81002?
- The event has 79 product records. The first record gives this quantity:
486 milliliters
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.