Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Reported: November 5, 2014 Initiated: August 27, 2014 #D-0088-2015
Product Description
Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Reason for Recall
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Details
- Recalling Firm
- Martin Avenue Pharmacy, Inc.
- Units Affected
- 40 mL
- Distribution
- Nationwide
- Location
- Naperville, IL
Frequently Asked Questions
What product was recalled? ▼
Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.. Recalled by Martin Avenue Pharmacy, Inc.. Units affected: 40 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2014. Severity: Moderate. Recall number: D-0088-2015.
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