Drug recall: Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Class II FDA enforcement event 64716. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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
Pallimed Solutions started this drug recall on 25 Mar 2013. The firm address in the FDA record is in Woburn, MA. FDA put the recall in Class II. FDA event 64716 has 25 product records. The first FDA enforcement report date is 21 Aug 2013. The record gives the status Terminated, with the termination date 21 Aug 2013.
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
Pallimed Solutions, Woburn, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
25 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-857-2013 | Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 1 vial | Class II | Terminated | 21 Aug 2013 |
| D-858-2013 | Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 408 vials | Class II | Terminated | 21 Aug 2013 |
| D-859-2013 | Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-860-2013 | Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-861-2013 | BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 246 vials | Class II | Terminated | 21 Aug 2013 |
| D-862-2013 | Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 71 vials | Class II | Terminated | 21 Aug 2013 |
| D-863-2013 | Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 23 vials | Class II | Terminated | 21 Aug 2013 |
| D-864-2013 | Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-865-2013 | Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 7 vials | Class II | Terminated | 21 Aug 2013 |
| D-866-2013 | Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-867-2013 | DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 3 vials | Class II | Terminated | 21 Aug 2013 |
| D-868-2013 | Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-869-2013 | HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 261 vials | Class II | Terminated | 21 Aug 2013 |
| D-870-2013 | Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA | Class II | Terminated | 21 Aug 2013 | |
| D-871-2013 | Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 3 vials | Class II | Terminated | 21 Aug 2013 |
| D-872-2013 | MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 18 vials | Class II | Terminated | 21 Aug 2013 |
| D-873-2013 | Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 56 vials | Class II | Terminated | 21 Aug 2013 |
| D-874-2013 | Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 2 vials | Class II | Terminated | 21 Aug 2013 |
| D-875-2013 | Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-876-2013 | Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 | |
| D-877-2013 | Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 10 vials | Class II | Terminated | 21 Aug 2013 |
| D-878-2013 | Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA | 597 vials | Class II | Terminated | 21 Aug 2013 |
| D-879-2013 | Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | 862 vials | Class II | Terminated | 21 Aug 2013 |
| D-880-2013 | Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA | 12 vials | Class II | Terminated | 21 Aug 2013 |
| D-881-2013 | Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Class II | Terminated | 21 Aug 2013 |
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 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 25
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-857-2013The 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 64716. https://recallregister.com/fda/ii/64716/. 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 64716?
- The event has 25 product records. The first record gives this quantity:
1 vial
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.