FDA (Drugs) recall action 93103

Central Admixture Pharmacy Services Inc recalled 32 products on 2023-10-11

The FDA (Drugs) publishes a recall like this one as 32 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 32 pages.

Products: 32
Announced: 2023-10-11
Critical: 0
Units: 7,038

Why these products were recalled

Lack of assurance of sterility:

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 32

HighFDA (Drugs)··2023-10-11
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
Fentanyl 1,250 mcg/25 mL syringes from Central Admixture Pharmacy Services Inc are being recalled nationwide due to lack of assurance of sterility. The manufacturer could not confirm that affected lots meet required sterility standards.
Product
fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
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0 states
HighFDA (Drugs)··2023-10-11
Injectable Lidocaine Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.
Product
lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
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HighFDA (Drugs)··2023-10-11
Midazolam Injectable Solution Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.
Product
midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
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HighFDA (Drugs)··2023-10-11
HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
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HighFDA (Drugs)··2023-10-11
Ephedrine Injectable Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.
Product
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
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HighFDA (Drugs)··2023-10-11
Ketamine syringes recalled for lack of sterility assurance
CAPS Inc. is recalling 4,775 ketamine syringes nationwide due to lack of confirmed sterility assurance during manufacturing. No illnesses have been reported, but affected healthcare facilities should quarantine and return unused product.
Product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
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HighFDA (Drugs)··2023-10-11
FDA recalls HYDROmorphone injectable syringes for sterility assurance defect
The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.
Product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
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HighFDA (Drugs)··2023-10-11
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.
Product
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
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HighFDA (Drugs)··2023-10-11
FDA Recalls Fentanyl Injectable for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).
Product
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
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0 states
HighFDA (Drugs)··2023-10-11
Fentanyl and Bupivacaine Injectable Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
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0 states
HighFDA (Drugs)··2023-10-11
Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling 1,762 fentanyl syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
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0 states
HighFDA (Drugs)··2023-10-11
Phenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.
Product
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
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HighFDA (Drugs)··2023-10-11
Phenylephrine injectable drug recalled due to sterility assurance failure
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
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HighFDA (Drugs)··2023-10-11
FDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.
Product
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
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HighFDA (Drugs)··2023-10-11
Fentanyl Injectable Solution Recalled for Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.
Product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
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HighFDA (Drugs)··2023-10-11
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
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HighFDA (Drugs)··2023-10-11
Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect
Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses nationwide.
Product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
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HighFDA (Drugs)··2023-10-11
Injectable Succinylcholine Syringes Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc is recalling 3,590 succinylcholine 200 mg/10 mL syringes distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
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HighFDA (Drugs)··2023-10-11
HYDROmorphone Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,550 syringes of HYDROmorphone due to lack of assurance of sterility. The product was distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
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HighFDA (Drugs)··2023-10-11
Fentanyl in Dextrose Syringes Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.
Product
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2
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HighFDA (Drugs)··2023-10-11
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
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HighFDA (Drugs)··2023-10-11
FDA Recalls Injectable Fentanyl-Bupivacaine Mixture for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl-bupivacaine injectables due to lack of assurance of sterility. The recalled 250 mL bags were distributed nationwide.
Product
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
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HighFDA (Drugs)··2023-10-11
Fentanyl Injection Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 403 bags of fentanyl injection due to lack of sterility assurance. The affected lots were distributed nationwide.
Product
fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
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HighFDA (Drugs)··2023-10-11
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
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HighFDA (Drugs)··2023-10-11
Fentanyl Injectable Solution Recalled Over Sterility Concerns
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
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