Guardian Pharmacy Recalls Morphine Sulfate CADD Due to Sterility Concerns
Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.
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 recall is classified as FDA Class II and involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Guardian Pharmacy Services is recalling 20 units of Morphine Sulfate 1 mg/mL CADD 25 mL. The product is prescription-only and was compounded by Guardian Pharmacy Services in Dallas, Texas. The recall is being conducted due to a lack of sterility assurance.
The affected lots are 58440:42 (Use By: 05/23/2018), 58624:42 (Use By: 06/11/2018), and 58962:42 (Use By: 07/11/2018). The product was distributed in Texas.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded Injectable
- Hazard
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 (3)
- Lots: 58440:42 Use By: 05/23/2018
- 58624:42 Use By: 06/11/2018
- 58962:42 Use By: 07/11/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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