The Recall Desk
SevereFDA (Drugs)·D-0713-2021·Announced 2021-08-18

Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility

Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I by the agency, which mandates a minimum severity score of 4. Non-sterility in injectable drugs carries significant risk of serious infection and harm when administered intravenously or intramuscularly, supporting the Severe classification.

Plain-English summary

Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable in 21 mL syringes in two strengths: 5MG-25MG-5MG/ML and 1MG-2MG-100MCG/ML. The recall was initiated due to non-sterility of the product. This is an Rx-only medication manufactured and distributed by Med Shop Total Care Inc. in Longview, Texas.

The affected products were distributed in Texas and Puerto Rico. The specific lot numbers recalled are: Lot #09302020@31 (BUD 10/28/2020) and Lot #09302020@29 (BUD 10/30/2020).

This recall was initiated voluntarily by the firm on October 5, 2020, and was classified as FDA Class I. The recall was terminated on August 17, 2023. Healthcare providers and patients who have received this product should consult with their healthcare provider regarding appropriate steps, given the non-sterility concern with an injectable medication.

The recalled product

Product
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Manufacturer
Med Shop Total Care Inc.
Category
Drug — Injectable / Compounded
Hazard
  • non-sterility
  • infection-risk
  • contamination

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 (4)

  • Lot #: 09302020@31
  • BUD 10/28/2020
  • b) 09302020@29
  • BUD 10/30/2020

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category