The Recall Desk
SevereFDA (Drugs)·D-0717-2021·Announced 2021-08-18

Hydromorphone HCL-Bupivacaine HCL Injectable Recalled for Non-Sterility

Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.

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 for a non-sterile injectable drug product. Class I recalls require a score of at least 4 per the rubric. Non-sterile injectable medications pose significant risk of serious infection if administered to patients.

Plain-English summary

Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths. The injectable is available in 16 different strength combinations ranging from 0.5 mg-5 mg/mL to 50 mg-3.5 mg/mL. The product is distributed in Texas and Puerto Rico.

The recall was initiated due to non-sterility of the product. The manufacturer determined that multiple lots did not meet sterility requirements. Specific lot numbers affected include 09302020@40, 09292020@55, 09302020@58, 10012020@6, 09302020@23, 10012020@4, 10012020@11, 10012020@64, 10022020@22, 10012020@15, 10012020@41, 09282020@92, 10012020@20, 09302020@9, 09292020@36, 09302020@11, and 09302020@18, with expiration dates ranging from October 27, 2020 to October 30, 2020.

The recall is voluntary and was initiated by the firm. Patients and healthcare providers who received this product should consult their healthcare provider or contact Med Shop Total Care Inc. at 470 East Loop 281, Longview, TX 75605 regarding use or return of affected lots.

The recalled product

Product
HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5M
Manufacturer
Med Shop Total Care Inc.
Category
Drug — Injectable / Pain Management
Hazard
  • non-sterility
  • 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) 09302020@40
  • BUD 10/28/2020
  • b) 09292020@55
  • BUD 10/27/2020
  • c) 09302020@58
  • BUD 10/29/2020
  • d) 10012020@6
  • e) 09302020@23
  • f)10012020@4
  • g) 10012020@11 BUD 10/29/2020
  • h) 10012020@64
  • i)10022020@22
  • j) 10012020@15 BUD 10/30/2020
  • k) 10012020@41 BUD 10/29/2020
  • l) 09282020@92
  • m)10012020@20 BUD 10/30/2020
  • n) 09302020@9
  • o) 09292020@36
  • p) 09302020@11
  • q) 09302020@18

Distribution

Distribution scope not specified by the agency.

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