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Abbotts Compounding Pharmacy voluntarily recalls all unexpired lots of sterile compounded products for humans and animals due to sterility concerns
Recalled products were distributed exclusively in California beginning in January 2015.
Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products for humans and animals due to concerns of lack of sterility assurance, according to a Food and Drug Administration (FDA) release. These products include injectable medications, sterile solutions, eye drops and eye ointments, all of which were distributed to patients, physician offices, clinics and veterinarians in California. All unexpired lots are subject to the recall, and have an expiration date between 01/01/2015 and 01/14/2016.
The recall was issued after a series of onsite inspections conducted by the FDA. If there is contamination in products intended to be sterile, patients are at risk for serious infections, the release says. To date the company has not received reports of any adverse effects or injuries, and the products were distributed exclusively in California from its Berkeley, California location.
The recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. If unsure, customers can call the pharmacy to determine the expiration date, the release states. Customers with recalled product should stop using it immediately and contact the pharmacy to arrange for a return of unused product, and should contact their healthcare provider or veterinarian if they have experienced any problems that may be related to using these products.
For more information or questions, contact Abbott's Compounding Pharmacy by calling (510) 548-8777.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
> Complete and submit the report online
> Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
> For reporting animal adverse drug events