Abrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes
Abrams Royal Pharmacy is recalling 50 syringes of a compounded lidocaine and bupivacaine mixture due to non-sterility. The products were distributed in Texas.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which is the highest severity level indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Plain-English summary
Abrams Royal Pharmacy in Dallas, Texas, is voluntarily recalling 50 syringes of a compounded medication containing lidocaine, bupivacaine, epinephrine, and hyaluronidase. The FDA has classified this recall as Class I, the most serious type, because the products were found to be non-sterile.
The affected products are supplied in 11 mL sterile syringes and are marked for single use only. The specific lot number is 041013-13 (also written as "041013@13") with an expiration date of 06/09/2013. The recall was initiated on April 19, 2013, and the products were distributed in Texas.
Consumers and healthcare providers should stop using the affected syringes immediately. The recall status is currently terminated, having been closed on October 7, 2016.
The recalled product
- Product
- Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
- Manufacturer
- Abrams Royal Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 50
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# 041013-13 (also been written as "041013@13") Exp: 06/09/2013
Distribution
Distributed in 1 state:
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