Compounded Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ injectable due to lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a compounded injectable drug. Lack of sterility assurance in injectable products presents a serious infection risk, and injectables that lack sterility assurance fall under FDA Class II, which combined with the route of administration (injectable) and potential for serious harm justifies a Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ (Rx only). The recall involves 3 vials of Lot 06292021:27 with a Beyond Use Date of 10/23/2021.
The product is being recalled because the manufacturer cannot assure the product's sterility. This injectable compound is distributed throughout the United States including Washington, D.C. and Puerto Rico.
Patients who have received this product should consult their healthcare provider. Healthcare providers should not administer this product and should contact their patients if doses were dispensed. Consumers with questions should contact their healthcare provider or pharmacy.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 06292021:27 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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