The Recall Desk
HighFDA (Drugs)·D-1549-2016·Announced 2016-10-05

FDA Recalls Vital Care Compounder DMSO and Lidocaine Vials for Sterility Concerns

Pharmacy Plus, Inc. is recalling specific lots of DMSO 50% with Lidocaine 0.5% vials due to a lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a sterile product with a lack of assurance of sterility, which poses a risk of harm where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for DMSO 50% with Lidocaine 0.5%, 50ml single-dose vials manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall affects Lot # 389321, which has a use-by date of 3/10/17. The product is a prescription sterile compound.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product was distributed in Mississippi. Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or the recalling firm for further instructions or a replacement.

The recalled product

Product
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Affected units
6

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 (2)

  • Lot # 389321
  • Use by 3/10/17

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 21 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →