The Recall Desk
SevereFDA (Drugs)·D-0710-2021·Announced 2021-08-18

Morphine-Bupivacaine Injectable Recalled for Non-Sterility

Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.

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: The FDA has classified this as a Class I recall of an injectable drug due to non-sterility, which meets the "Severe" threshold as non-sterile injectables pose significant risk of infection and serious harm. Although no reported illnesses or injuries are stated in the source text, the agency's own Class I classification and the nature of the hazard (non-sterility in an injectable product) warrant a score of 4.

Plain-English summary

Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes available in 21 mL, 22 mL, 23 mL, 41 mL, and 43 mL sizes in multiple strength combinations. The recall was initiated due to non-sterility concerns.

The affected product was distributed to Texas and Puerto Rico. Multiple lot numbers are included in the recall, with best-by dates ranging from October 27, 2020 to October 30, 2020. The affected lots span various strength formulations of the morphine-bupivacaine combination.

This is a Class I recall, meaning the product may cause serious adverse health consequences or death. The recalling firm initiated this recall voluntarily on October 5, 2020. Healthcare providers and patients who have received or are in possession of affected units should discontinue use and contact Med Shop Total Care Inc. at 470 East Loop 281, Longview, TX 75605.

The recalled product

Product
MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.
Manufacturer
Med Shop Total Care Inc.
Category
Drug — Injectable / Parenteral
Hazard
  • non-sterility
  • infection-risk
  • microbial-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 (20)

  • Lot #: a) 09282020@62
  • BUD 10/27/2020
  • 09302020@25
  • BUD 10/29/2020
  • b) 09292020@56
  • c) 09292020@58
  • d)09292020@60
  • e) 09292020@66
  • 09292020@73
  • f) 09292020@70
  • g) 09292020@71
  • h) 09292020@77
  • i) 09302020@20 j) 09302020@33
  • k) 09302020@48
  • l) 09302020@61
  • m) 09302020@66
  • n) 09302020@70
  • o) 09302020@26
  • p) 10012020@8
  • q) 10022020@20

Distribution

Distribution scope not specified by the agency.

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