Teva Recalls Epinephrine Auto-Injectors Due to CGMP Deviations
Teva Pharmaceuticals is recalling Epinephrine Injection USP auto-injectors due to out-of-specification trigger force. The product was not distributed to the public.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the product was not distributed to the public and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall with low risk.
Plain-English summary
Teva Pharmaceuticals USA is recalling Epinephrine Injection USP, 0.3 mg (Auto-Injector), NDC 0093-5986-27. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically out-of-specification results for trigger force in a non-marketed lot that shares the same component.
The affected product is Lot # 007F19AA with an expiration date of 04/2021. The recall involves 600 cartons, with two auto-injectors per carton. The product was distributed to one wholesaler, which still possesses all units and has not shipped or further distributed any of the product.
Because the product was not distributed to the public, no consumers are currently affected. No action is required for the general public. Healthcare providers and wholesalers should follow standard recall procedures to ensure the product is not dispensed.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Injection
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 # 007F19AA
- exp. date 04/2021
UPCs (2)
- 0300935985275
- 0300935986272
Distribution
Distribution scope not specified by the agency.
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