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The Compounding Pharmacy of America Recall: Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml

The Compounding Pharmacy of America Recall: Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: The Compounding Pharmacy of America; Product: Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intratheca

Recalling firmThe Compounding Pharmacy of America
ProductHydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Reason for recallLack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide
Recall initiated20150602
Recall numberD-1682-2015
Categorydrug
StateTN
CountryUnited States

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