The Recall Desk
SevereFDA (Drugs)·D-0711-2021·Announced 2021-08-18

Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl

Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in 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 classified this as a Class I recall, which mandates a severity score of at least 4 per the rubric. Non-sterile injectable medications containing potent opioids and local anesthetics present serious risk of systemic infection and adverse effects; no reported illnesses are mentioned in the source text.

Plain-English summary

Med Shop Total Care Inc. is recalling HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE in 21 mL syringes due to non-sterility. The recalled product is available in three strength formulations: (a) 10 mg-20 mg-100 mcg/mL, (b) 20 mg-10 mg-450 mcg/mL, and (c) 13.3 mg-3 mg-3000 mcg/mL. The affected lot numbers are: a) 09282020@66 (BUD 10/27/2020), 09302020@42 (BUD 10/29/2020); b) 09282020@79; and c) 09292020@32 (BUD 10/27/2020). A total of 84 mL was distributed.

The products were distributed to customers in Texas and Puerto Rico. This is a voluntary recall initiated by the manufacturer. The recall was reported to the FDA on August 18, 2021, and was formally initiated on October 5, 2020.

Patients who have received this injectable medication should contact their healthcare provider immediately. Healthcare facilities that received these products should quarantine affected lots and verify patient status with prescribers. The recall was terminated on August 17, 2023.

The recalled product

Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Manufacturer
Med Shop Total Care Inc.
Category
Drug — Injectable / Parenteral
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 (6)

  • Lot #: a) 09282020@66
  • BUD 10/27/2020
  • 09302020@42
  • BUD 10/29/2020
  • b) 09282020@79
  • c) 09292020@32

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category