Synthetopes Recalls Sulfur Colloid Reaction Vials Due to Processing Controls
Synthetopes Inc. is recalling Sulfur Colloid Reaction Vials nationwide due to a lack of processing controls.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Synthetopes Inc. is recalling 20 vials of Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen. The recall is being conducted because of a lack of processing controls.
The affected product is distributed nationwide. The recall includes all lots remaining within their expiry dates.
Consumers and healthcare providers should stop using the recalled product and contact Synthetopes Inc. for further instructions or a refund.
The recalled product
- Product
- Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Biological / Diagnostic
- Hazard
- Affected units
- 20
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Synthetopes Inc 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 8 products in this recall →Related recalls
Same manufacturer · Synthetopes Inc
See all →- SevereSynthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls
FDA (Drugs) · 2019-06-19
- SevereSynthetopes Recalls Sn-Tetrofosmin Kits Due to Processing Control Deficiencies
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sn-Mertiatide Kit Due to Processing Control Deficiencies
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sn-Pyrophosphate Kits Due to Processing Control Issues
FDA (Drugs) · 2019-06-19
Same hazard · processing defect
See all →- SevereWayne Farms Recalls Undercooked Ready-to-Eat Chicken Breast Products
USDA FSIS · 2023-12-07
- HighUndercooked Ready-to-Eat Stuffed Chicken Product Subject to Public Health Alert
USDA FSIS · 2023-02-03
- SevereWayne Farms Recalls Undercooked Ready-to-Eat Chicken Breast Fillets
USDA FSIS · 2022-04-29
- ModerateMasterPharm Recalls Tadalafil 18 mg Capsules Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
- SevereMasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies
FDA (Drugs) · 2020-08-05
Similar recalls
- ModerateWise Pharmacy Recalls Dexamethasone Sodium Phosphate Injection Due to Processing Controls
FDA (Drugs) · 2019-08-07
- LowHF Acquisition Recalls Famotidine Injection Due to Temperature Abuse
FDA (Drugs) · 2020-07-29
- SevereUS Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereZydus Recalls Acyclovir Sodium Injection Due to Crystallization
FDA (Drugs) · 2021-04-07
- ModerateWise Pharmacy Recalls Alprostadil Injectable Due to Lack of Processing Controls
FDA (Drugs) · 2019-08-07
- SevereMedaus Recalls Manganese Sulfate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20