Injectable drug recalled for non-sterility concerns in Texas and Puerto Rico
Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots 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 requires a minimum score of 4. Non-sterile injectable drugs present a significant risk of serious infection and harm when administered directly into the body.
Plain-English summary
Med Shop Total Care Inc. is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL (a combination pain and anesthetic medication) due to non-sterility concerns. The affected products are 21 mL syringes in two strengths: strength a) 20MG-20MG-60MCG/ML and strength b) 5MG-5MG-100MCG/ML.
The recall involves specific lots with the following identifiers: Lot #09302020@30 (BUD 10/23/2020) for strength a, and Lot #10022020@14 (BUD 10/30/2020) for strength b. A total of 42 mL of product was distributed to Texas and Puerto Rico.
This is a prescription-only (Rx) medication. Patients who have received injections from affected lots should contact their healthcare provider for guidance. Healthcare facilities and pharmacies that received this product should cease use and initiate patient notification if necessary. The product is manufactured by and recalled from Med Shop Total Care Inc., located at 470 East Loop 281, Longview, TX 75605.
The recalled product
- Product
- HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
- Manufacturer
- Med Shop Total Care Inc.
- Category
- Drug — Injectable
- 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 (4)
- Lot #: a) 09302020@30
- BUD 10/23/2020
- b) 10022020@14
- BUD 10/30/2020
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27