Fresenius Kabi Recalls Propranolol Hydrochloride Injection Due to API Deficiencies
Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.
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 the source explicitly cites 'critical deficiencies' in the active ingredient, which aligns with the rubric criteria for Severe severity involving significant quality issues.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection, USP 1 mg/mL, 1 mL Single Dose Vial. The affected product is identified by Lot 6007698 with an expiration date of 03/16. The product is distributed nationwide and in Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The Italian Health Agency (AIFA) issued citations to the active pharmaceutical ingredient (API) supplier for several critical deficiencies. These deficiencies resulted in a recall of the specific API lot used to manufacture the affected Propranolol Hydrochloride Injection.
Healthcare providers and patients should discontinue use of the affected vials and contact their healthcare provider for alternatives. Consumers should check their medication for the specific lot number and expiration date listed above.
The recalled product
- Product
- PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)
- Brand
- PROPRANOLOL
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Affected units
- 56,060
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 (2)
- Lot 6007698
- Exp. 03/16
UPCs (1)
- 0363323604004
Distribution
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