Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol
Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use 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. Per the rubric, FDA Class I recalls are assigned a score of 5.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 5 syringes of Atropine Sulfate 0.4 mg/ml Injection, USP. The product is a 3 mL pre-filled syringe with a total dosage of 0.8 mg per 2 mL. The specific lot number is E0333282R, and the expiration date is 7/13/2014.
The recall was initiated because the product contains an incorrect or undeclared excipient, specifically benzyl alcohol. This ingredient was not declared on the product labeling.
The affected product was distributed in the United States to the states of Texas, Illinois, Maryland, and Indiana. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be discontinued and returned to the distributor or manufacturer.
The recalled product
- Product
- Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injection
- Hazard
- Affected units
- 5
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 #: E0333282R
- Exp: 7/13/2014
Distribution
Part of a larger recall action
This product is one of 4 recalled by Pharmakon Pharmaceuticals 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals
See all →- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- ModeratePharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03
Same hazard · undeclared excipient
See all →- CriticalLubrisine eye drops recalled for undeclared colloidal silver and sterility issues
FDA (Drugs) · 2018-12-26
- ModerateImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling
FDA (Drugs) · 2017-09-13
- ModerateImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13
- SevereImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13
- SevereImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient
FDA (Drugs) · 2017-09-13
Similar recalls
- SeverePharmakon Recalls Atropine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- SevereSCA Pharmaceuticals Recalls Atropine Sulfate Injection Due to Sterility Concerns
FDA (Drugs) · 2021-01-13
- ModeratePharmedium Recalls Atropine Sulfate Injection Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- HighAtropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
FDA (Drugs) · 2022-07-27
- SeverePremier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns
FDA (Drugs) · 2019-07-03