Class II · Moderate risk
Verapamil Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
HCG Chorionic Gonadotropin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Recalling firm
- Pallimed Solutions
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-869-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Pallimed Solutions
All 2013 recalls
Class II · Moderate risk
Vancomycin Ophthalmic PF
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Trimix Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Other sterility / contamination recalls from 2013
All sterility / contamination recalls
Class II · Moderate risk
All Unexpired Sterile Drug Products
Lack of Assurance of Sterility
Class I · High risk
MINERAL IV Injection
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Class II · Moderate risk
Vitamin B-12 injections
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class II · Moderate risk
Bupivacaine 3%
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.