The Recall Desk
SevereFDA (Drugs)·D-0708-2021·Announced 2021-08-18

Injectable Drug Syringes Recalled for Non-Sterility

Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were 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. According to the severity rubric, FDA Class I recalls without reported deaths receive a minimum score of 4 (Severe). Non-sterile injectable drugs pose direct risk of serious infection and hospitalization.

Plain-English summary

Med Shop Total Care Inc. is recalling injectable drug syringes in various strengths containing hydromorphone HCL, bupivacaine HCL, and baclofen PF. The recalled products are 21 mL syringes with six different strength formulations, supplied as a total of 126 mL. Specific lot numbers are: 10012020@42, 10012020@43, 10012020@44, 10012020@46, 09302020@16, and 09302020@44, all with a beyond-use date of 10/29/2020.

The recall was initiated due to non-sterility of the products. These are prescription-only injectable medications. The products were distributed to patients in Texas and Puerto Rico.

Patients who have received these injections should consult their healthcare provider immediately. Healthcare providers should not use remaining stock and should contact Med Shop Total Care Inc. for instructions on return or disposal of affected syringes. The recall was initiated by the firm on October 5, 2020, and was classified as a voluntary firm-initiated action.

The recalled product

Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
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 (7)

  • Lot #: a)10012020@42
  • b) 10012020@43
  • c) 10012020@44
  • d) 10012020@46
  • e) 09302020@16
  • f) 09302020@44
  • BUD 10/29/2020

Distribution

Distribution scope not specified by the agency.

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