Injectable Drug Recalled for Non-Sterility Risk
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was 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 recall as Class I, which per the rubric indicates a score of at least 4. Non-sterility of injectable drugs presents a significant risk of serious infection or harm when administered to patients. No reported illnesses are stated in the source, but the hazard itself justifies the Severe classification under Class I criteria.
Plain-English summary
Med Shop Total Care Inc. is recalling a compounded injectable drug product: HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE in 21 mL syringes. The product is a prescription-only injectable available from the firm located at 470 East Loop 281, Longview, TX 75605.
The recall was initiated due to non-sterility concerns. The affected lot is #09292020@59 with a beyond-use date of 10/28/2020. The product was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. initiated this recall voluntarily. The firm notified customers through email, fax, letter, press release, telephone, and direct visits. The recall was classified as Class I by the FDA on August 9, 2021, and the firm began the recall on October 5, 2020.
Patients who received or have this product should consult their healthcare provider immediately. The product should not be used.
The recalled product
- Product
- HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, 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
- injectable-contamination
- infection-risk
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 (1)
- Lot #: 09292020@59 BUD 10/28/2020
Distribution
Distribution scope not specified by the agency.
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